Arthrex® AR-7200Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00888867041264), received between Aug 30, 2017 and Jun 11, 2026 — classified as 14 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY THE SUTURES FROM THE DEVICE BROKE WHILE TIGHTENING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469644 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520071 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(6) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519924 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519907 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519900 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519899 ↗
• MalfunctionDec 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 11/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-7200 FIBERWIRE #2 BRAIDED POLYBLEND SUTURE WAS CUT WHEN THE FIRST KNOT WAS MADE. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744028 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE JOINT RECONSTRUCTION SURGERY THE TIP OF A FIBERWIRE NEEDLE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251266 ↗
• InjuryJun 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE, AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 5/15/2024: THE PATIENT HAS NOT UNDERGONE REVISION SURGERY, AND NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS INCIDENT.

  Patient problems: Unspecified Infection

  MAUDE report 19533131 ↗
• InjuryJun 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 5/15/2024: THE PATIENT HAS NOT UNDERGONE REVISION SURGERY, AND NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THIS INCIDENT.

  Patient problems: Unspecified Infection

  MAUDE report 19532577 ↗
• MalfunctionJun 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE SUTURES ARE TORN OFF CLOSE TO THE IMPLANT. THIS HAPPENED WITH 6 DEVICES AND THE SUTURES TORE AT THE SAME PLACE. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SURGEON HAD TO SWITCH TO OPEN SURGERY TO FINISH THE CRUCIATE LIGAMENT SURGERY. THE SURGERY TOOK MORE THAN 3 HOURS DUE TO THE DEVICE FAILURES. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19466898 ↗
• MalfunctionJun 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE SUTURES ARE TORN OFF CLOSE TO THE IMPLANT. THIS HAPPENED WITH 6 DEVICES AND THE SUTURES TORE AT THE SAME PLACE. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SURGEON HAD TO SWITCH TO OPEN SURGERY TO FINISH THE CRUCIATE LIGAMENT SURGERY. THE SURGERY TOOK MORE THAN 3 HOURS DUE TO THE DEVICE FAILURES. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19466786 ↗
• MalfunctionJun 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE SUTURES ARE TORN OFF CLOSE TO THE IMPLANT. THIS HAPPENED WITH 6 DEVICES AND THE SUTURES TORE AT THE SAME PLACE. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SURGEON HAD TO SWITCH TO OPEN SURGERY TO FINISH THE CRUCIATE LIGAMENT SURGERY. THE SURGERY TOOK MORE THAN 3 HOURS DUE TO THE DEVICE FAILURES. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19466729 ↗
• InjuryJun 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE SUTURES ARE TORN OFF CLOSE TO THE IMPLANT, THIS HAPPENED WITH 6 DEVICES AND THE SUTURES TORE AT THE SAME PLACE. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SURGEON HAD TO SWITCH TO OPEN SURGERY TO FINISH THE CRUCIATE LIGAMENT SURGERY. THE SURGERY TOOK MORE THAN 3 HOURS DUE TO THE DEVICE FAILURES. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19464089 ↗
• MalfunctionJun 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE SUTURES ARE TORN OFF CLOSE TO THE IMPLANT, THIS HAPPENED WITH 6 DEVICES AND THE SUTURES TORE AT THE SAME PLACE. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SURGEON HAD TO SWITCH TO OPEN SURGERY TO FINISH THE CRUCIATE LIGAMENT SURGERY. THE SURGERY TOOK MORE THAN 3 HOURS DUE TO THE DEVICE FAILURES. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19463784 ↗
• MalfunctionJun 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A CRUCIATE LIGAMENT SURGERY, THE SUTURES ARE TORN OFF CLOSE TO THE IMPLANT. THIS HAPPENED WITH 6 DEVICES AND THE SUTURES TORE AT THE SAME PLACE. ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SURGEON HAD TO SWITCH TO OPEN SURGERY TO FINISH THE CRUCIATE LIGAMENT SURGERY. THE SURGERY TOOK MORE THAN 3 HOURS DUE TO THE DEVICE FAILURES. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19461138 ↗
• InjuryFeb 6, 2023Use of Device Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 16303002 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/18/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1400TB BIO-INTERFERENCE SCREW FULL THREAD, AN AR-1588T ACL TIGHTROPE, (3) AR-2324BCC-2 BIO COMPOSITE SWIVELOCK, (3) AR-4500 MENISCAL CINCH, (4) AR-7200 FIBERWIRE, AND (2) AR-7237 FIBERTAPE WERE ALL IMPLANTED IN THE PATIENT. THIS ACL AND LIGAMENT PROCEDURE TOOK PLACE ON (B)(6) 2023. PATIENT DEVELOPED AN INFECTION POST OPERATIVE AND PATIENT REMAINS ADMITTED TO THE HOSPITAL FOR TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 16302993 ↗
• MalfunctionMar 1, 2021Break

  IT WAS REPORTED THAT DURING AN ACL BTB, WHEN THE SURGEON WAS USING THE SCORPION FORCEPS AND WHEN PASSING THE NEEDLE, THE AR-7200 BROKE. ALL FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED BY USING ANOTHER AR-7200 WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393415 ↗
• MalfunctionFeb 9, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE AR-7200, SUTURE DISASSEMBLED FROM THE NEEDLE AT THE POINT OF PASSING THE DEVICE. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED BY USING ANOTHER OF THE AR-7200 WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301024 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO A METALLOSIS THE SHOULDER AND THE ARM OF THE PATIENT TURNED BLACK. THE SURGERY WHICH LED TO THE REPORTED EVENT WAS A SHOULDER PROSTHESIS WHICH WAS PERFORMED ON (B)(6) 2015. ACCORDING TO THE CUSTOMER ARTHREX DEVICES WERE IMPLANTED DURING THE INITIAL SURGERY IN 2015. CURRENTLY IT IS NOT KNOWN IN WHICH HOSPITAL THE INITIAL SURGERY TOOK PLACE. THEREFORE NO FURTHER INFORMATION ABOUT THE DETAILED INCIDENT AND THE USED ARTHREX PART NUMBERS ARE CURRENTLY AVAILABLE. UPDATE 12-OCT-2020: INITIALLY THE LOT NUMBERS WHICH WERE AFFECTED WERE NOT PROVIDED HOWEVER FURTHER INFORMATION WERE NOW PROVIDED THAT THE FOLLOWING PARTS WERE USED DURING THE INITIAL SURGERY 2015: AR-9120-01, LOT: 140113110. AR-9145-30, LOT: 140123108. AR-9504S-04, LOT: 2501212801. AR 9165-15, LOT: 140103207. AR-9145-30, LOT: 2501417704. AR-9502-36CPC, LOT: 140120310. AR -9501-07CPC, LOT: 2501215303. AR-9503S-03, LOT: 140104307. AR-9555-15, LOT:2501215101. AR-7213, LOT: 12812. AR-7200, LOT: 12795. HOWEVER IT COULD NOT BE CONFIRMED WHICH DEVICE HAS LED TO THE REPORTED ISSUE AND IF THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: Metal Related Pathology; Skin Discoloration

  MAUDE report 10746482 ↗
• InjuryOct 12, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THREE FIBERWIRES, AR-7200, BROKE DURING THE INSERTION OF A BIO-SCREW. ALL SUTURE FRAGMENTS WERE RETRIEVED FROM THE PATIENT AND DISCARDED. THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED (B)(6) 2020: THE BROKEN END END OF THE FINAL CONSTRUCT IS IMPLANTED WITH THE SCREWS. ADDITIONAL INFORMATION PROVIDED (B)(6) 2020: THERE WERE A TOTAL OF 3 SUTURES USED CONSECUTIVELY AND ALL 3 SNAPPED AT ONE END. FOR THE FIRST 2 SUTURES USED, THE SURGEON REMOVED THEM WHEN THEY SNAPPED BUT FOR THE THIRD SUTURE, THE SURGEON LEFT IT IMPLANTED IN THE BONE WITH THE SCREWS.

  Patient problems: Foreign Body In Patient

  MAUDE report 10666727 ↗
• InjuryMar 13, 2020Break; Device Dislodged or Dislocated

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5092918) THAT WHILE A PATIENT WAS UNDERGOING SURGICAL REPAIR OF THE LEFT PATELLA TENDON, A NEEDLE TIP BEING USED BROKE OFF AND LODGED IN THE PATIENT'S PATELLA TENDON. THE NEEDLE TIP WAS LEFT IN PLACE AS REMOVING IT WOULD HAVE CAUSED MORE HARM THAN LEAVING IT WHERE IT WAS. THE FDA MEDWATCH LETTER DID NOT CONTAIN ANY FACILITY NAME OR CONTACT INFORMATION. THEREFORE, AT THIS TIME NO FURTHER INFORMATION IS ABLE TO BE OBTAINED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9828871 ↗
• InjuryFeb 26, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE A PORTION OF THE TIP ON THE AR-7200 FIBERWIRE # 2 BRAIDED POLYBLEND SUTURE W/ TAPERED NEEDLE BROKE OFF INSIDE THE PATIENT (APPROX. 2MM). THE FACILITY REPORTED X-RAY AND C-ARM CONFIRMED THE FOREIGN SUBJECT TO BE IN THE PATIENT'S KNEE (NOT AFFECTING THE JOINT OR LIGAMENTS). ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 02/11/2020: THE FACILITY REPORTED THE PROCEDURE TAKING PLACE WAS A PRIMARY PATELLAR TENDON REPAIR. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE CASE. THE TIP OF THE DEVICE BROKE OFF DURING THE ACTUAL TENDON REPAIR. THE KNEE WAS FLUSHED, AND A FLAT PLATE X-RAY OF THE KNEE DONE AND C-ARM WAS USED TO LOCATE THE TIP. AFTER DETERMINING THE LOCATION, NO FURTHER ATTEMPT WAS MADE TO RETRIEVE THE BROKEN TIP. THE FACILITY REPORTED THE SURGEON DOES NOT PLAN TO PERFORM A SECOND SURGERY. THE COMPLAINT DEVICE (MINUS THE UN-RETRIEVED BROKEN TIP) WILL BE RETURNING FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9756011 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD SURGERY ON (B)(6) 2019 TO REPAIR A TORN ACHILLES TENDON USING ARTHREX FIBERWIRE SUTURES. APPROXIMATELY 6 WEEKS POST OP THE PATIENT BEGAN EXPERIENCING PAIN, SWELLING AND OOZING NEAR THE SURGICAL SITE. THE PATIENT TESTED POSITIVE FOR STAPH INFECTION AND HAS BEEN TREATED WITH ANTIBIOTICS. THE ISSUES CONTINUE TO COME BACK AND HE CONTINUES TO BE TREATED WITH ANTIBIOTICS ON AND OFF EACH TIME THE SYMPTOMS REAPPEAR. THE PATIENT'S ALLERGIST HAS REQUESTED THAT HE OBTAIN THE MATERIAL COMPOSITION OF THE IMPLANTS AND HAS REQUESTED THAT A SAMPLE OF THE PRODUCT BE PROVIDED TO THE ALLERGIST FOR PATCH TESTING TO DETERMINE IF THE PATIENT MAY BE ALLERGIC TO THE IMPLANT MATERIALS. AT TIME OF INITIAL REPORT THE PATIENT DID NOT KNOW THE ACTUAL ARTHREX PRODUCT NUMBER BUT WILL OBTAIN IT AND PROVIDE TO ARTHREX. ADDITIONAL INFORMATION OBTAINED 02/04/2020: THE PATIENT HAS REPORTED THAT HE HAD SECOND SURGERY ON (B)(6) 2019 AT A DIFFERENT FACILITY BY A DIFFERENT SURGEON THAN THE ORIGINAL PROCEDURE. DURING THE SECOND PROCEDURE THE SURGEON REMOVED THE FIBERWIRE FROM THE PATIENT. DURING DEBRIDEMENT THE SURGEON TOOK TISSUE SAMPLES WHICH WERE SENT TO THE LAB. THE SAMPLES T

  Patient problems: Bacterial Infection; Discharge; Pain; Swelling

  MAUDE report 9750591 ↗