Arthrex® AR-1370CRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867014633), received between Oct 14, 2016 and Mar 10, 2026 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Patient Device Interaction Problem

  UPDATE 16-MAR-2026: THE PATIENT CONFIRMED THAT THE INITIAL SURGERY TOOK PLACE IN (B)(6) AND CURRENTLY NO SECOND SURGERY IS PLANNED, ALTHOUGH THE SYMPTOMS ARE PERSISTENT SINCE (B)(6) 2025.

  Patient problems: Foreign Body Reaction

  MAUDE report 24563194 ↗
• MalfunctionJan 23, 2026Break

  ON 08-JAN-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1370C BIOCOMPOSITE INTERFERENCE SCREW BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN ACL PROCEDURE WITH NO PATIENT HARM. NO FRAGMENT REMAINED IN THE PATIENT AND THERE WAS NO DELAY IN THE PROCEDURE WITH NO ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163560 ↗
• MalfunctionJun 17, 2025Dull, Blunt; Failure to Advance; Dull, Blunt; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW WAS DULL AND COULD NOT BE INSERTED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236285 ↗
• MalfunctionNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  11/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1370C BIOCOMPOSITE INTERFERENCE SCREW AND AN AR-4020C-07 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW RIPPED THE SUTURE TIED TO THE GRAFT DURING THE FIXATION OF THE GRAFT TO THE FEMUR. THIS CAUSED THE GRAFT TO HAVE TO BE WHIP-STITCHED MULTIPLE TIMES. THE CASE WAS COMPLETED USING A BIOTENODESIS SCREW 8X23MM. THIS WAS DISCOVERED DURING AN MPFL RECONSTRUCTION PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 11/6/2024: THE SUTURE THAT BROKE WAS AN AR-7234 FIBERLOOP. THE CASE SUTURE WAS REMOVED AND REPLACED WITH ANOTHER AR-7234 FIBERLOOP. THE ANCHORS WERE ALSO REMOVED, AND AN AR-1580BC BIOCOMPOSITE-TENODESIS SCREW WAS USED. THERE WAS NO DELAY IN THE CASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784637 ↗
• MalfunctionSep 10, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREWDRIVER COULD NOT BE CONNECTED WITH THE SCREW. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181223 ↗
• MalfunctionJul 3, 2024Expiration Date Error; Expiration Date Error

  ON 6/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A BUTTON WENT THROUGH THE LATERAL CORTEX. THE SURGEON OPTED TO USE AN INTERFERENCE SCREW AND INSTEAD USED AN AR-1370C BIOCOMPOSITE INTERFERENCE SCREW WITH DISPOSABLE SHEATH; HOWEVER, THE IMPLANTED SCREW WAS EXPIRED. THE AR-1370C BIOCOMPOSITE INTERFERENCE SCREW EXPIRED ON 4/40/2024, AND IT WAS IMPLANTED SUCCESSFULLY. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19669399 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE BROKE WHILE SCREWING INTO THE BONE. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371120 ↗
• MalfunctionMay 22, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE THREAD WAS DAMAGED WHEN THE SREW WAS INSERTED INTO THE CHANNEL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369811 ↗
• MalfunctionJun 9, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE TIP OF THREE DIFFERENT IMPLANTS BROKE OFF. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH AN AR-5028C-09. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 17-MAY-2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON USED ALL THE REPORTED IMPLANTS DURING ONE SURGERY AND THEREFORE EXTENDED THE DRILL HOLE TO 9MM. IT WAS FURTHER REPORTED THAT A PART OF THE LAST IMPLANT WHICH WAS USED TO FINISH THE SURGERY BROKE OFF AS WELL. HOWEVER THE SURGEON WAS SATISFIED WITH THE FIXATION AND THEREFORE FINISHED THE SURGERY WITH THE DAMAGED IMPLANT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098323 ↗
• MalfunctionFeb 6, 2023Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE TIP OF THE SCREW BROKE DURING INSTALLATION. THE BROKEN TIP REMAINED IN PLACE AND WAS ENOUGH TO FIXATE THE SCREW. THE BROKEN-OFF END WAS RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303136 ↗
• MalfunctionOct 11, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT BTB SURGERY THE DEVICE BROKE. ACCORDING TO THE SURGEON 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 15576158 ↗
• MalfunctionApr 11, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1370C BIOCOMPOSITE INTERFERENCE SCREW TIP BROKE. BONE SOCKET WAS CREATED USING 9MM PRO REAMER AND IT WAS OF 25MM DEPTH, THE BONE BLOCK WAS 21MM LONG. AFTER REAMING, THE LARGE NOTCH WAS CREATED USING AR-1845 TUNNEL NOTCHER FOR BIO-INTERFERENCE SCREW. THE GRAFT WAS SHUTTLED IN PLACE AND A 1.1MM NITINOL WIRE WAS PLACED FOLLOWED BY A UNIVERSAL DILATOR TO THE SECOND LINE. THEN, A 7MM TAP WAS ADVANCE TO A DEPTH OF 25MM. WHEN THE AR-1370C BIOCOMPOSITE INTERFERENCE SCREW WAS INSERTED AND SCREWED IN ABOUT 75 PERCENT, THE TIP BROKE. SURGEON REMOVED THE SCREW LEAVING BEHIND THE TIP IN THE TUNNEL. AN AR-1370E SHEATHED CANNULATED INTERFERENCE SCREW WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ALLOGRAFT BTB ACL RECONSTRUCTION ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14075067 ↗
• MalfunctionNov 16, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY MULTIPLE SCREWS BROKE OR CRUMBLED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. 13-NOV-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE HE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN FRAGMENTS OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819462 ↗
• MalfunctionNov 16, 2021Break; Device Fell

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE WASN`T IN A GOOD CONDITION AND BROKE WHEN IT WAS IMPLANTED. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12819212 ↗
• MalfunctionAug 3, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DEVICE BROKE INSIDE THE PATIENT DURING IMPLANTATION. THE PROTRUDING PIECE OF THE DEVICE WAS PINCHED OFF WITH PLIERS. AND THE REST OF THE BROKEN PIECE REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12268218 ↗
• MalfunctionAug 3, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DEVICE BROKE INSIDE THE PATIENT DURING IMPLANTATION. THE PROTRUDING PIECE OF THE DEVICE WAS PINCHED OFF WITH PLIERS. AND THE REST OF THE BROKEN PIECE REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12268167 ↗
• InjuryAug 7, 2020Break

  IT WAS REPORTED THAT THE FEMORAL SCREW BROKE IN TWO PIECES DURING FIXATION OF THE ANTERIOR CRUCIATE LIGAMENT, USING THE KENNETH JONES TECHNIQUE. THE BROKEN SCREW REMAINS IN THE PATIENT, FIXING THE TENDON. NO ATTEMPTS WERE MADE TO REMOVE THE BROKEN [DISTAL] PART, THE DEVICE WAS USED ANYWAY TO COMPLETE THE SURGERY . THE PROXIMAL PART OF THE SCREW WAS RETRIEVED AND WILL BE RETURNED FOR INVESTIGATION. ACCORDING TO THE REPORTER, THIS EVENT POSES A RISK OF A LESS STABLE FIXATION OF THE TRANSPLANT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10379248 ↗
• InjurySep 4, 2019Break; Malposition of Device

  IT WAS REPORTED DURING AN ACL RECONSTRUCTION PROCEDURE, UPON INSERTING A QUANTITY THREE AR-1370C (LOT: 10284684 // QTY. 2 & LOT: 10292589 // QTY. 1) INTO THE FEMUR, APPROXIMATELY 7MM OF THE SCREW WOULD GO IN AND THEN BREAK. THE REP STATED THE 7MM PORTION OF THE SCREWS THAT WERE IN THE BONE TUNNEL REMAINED IMPLANTED AND THE BROKEN HEADS OF THE SCREWS WERE RETRIEVED. THE GRAFT DEEMED ADEQUATE FIXATION AND THE CASE WAS COMPLETED. HOWEVER, THE REP STATED THE REHAB WILL BE SLOWER BASED ON THE FIXATION ONLY BEING ADEQUATE AND NOT NORMAL OR IDEAL. A DILATOR WAS USED TO PREP THE BONE FOR THE FIRST SCREW, AND A TAP WAS USED FOR THE OTHER TWO SCREWS. THE BONE QUALITY WAS HARD. THE RETRIEVED SCREW HEADS WERE DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 08/26/2019: THE SALES REP REPORTED TO THE ARTHREX PRODUCT MANAGER THAT THE PATIENT HAD PARTICULARLY HARD BONE AND THE SURGEON DID NOT TAP THE BONE AS THEY NORMALLY WOULD IN THIS CASE. THE GRAFT ENDED UP WELL-FIXED, ALBEIT BY A SHORTER PIECE OF SCREW, AND THE SURGEON STATED TO THE REP THAT THEY SHOULD HAVE TAPPED THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961330 ↗
• InjurySep 4, 2019Break

  IT WAS REPORTED DURING AN ACL RECONSTRUCTION PROCEDURE, UPON INSERTING A QUANTITY THREE AR-1370C (LOT: 10284684 // QTY. 2 & LOT: 10292589 // QTY. 1) INTO THE FEMUR, APPROXIMATELY 7 MM OF THE SCREW WOULD GO IN AND THEN BREAK. THE REP STATED THE 7 MM PORTION OF THE SCREWS THAT WERE IN THE BONE TUNNEL REMAINED IMPLANTED AND THE BROKEN HEADS OF THE SCREWS WERE RETRIEVED. THE GRAFT DEEMED ADEQUATE FIXATION AND THE CASE WAS COMPLETED. HOWEVER, THE REP STATED THE REHAB WILL BE SLOWER BASED ON THE FIXATION ONLY BEING ADEQUATE AND NOT NORMAL OR IDEAL. A DILATOR WAS USED TO PREP THE BONE FOR THE FIRST SCREW, AND A TAP WAS USED FOR THE OTHER TWO SCREWS. THE BONE QUALITY WAS HARD. THE RETRIEVED SCREW HEADS WERE DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 08/26/2019: THE SALES REP REPORTED TO THE ARTHREX PRODUCT MANAGER THAT THE PATIENT HAD PARTICULARLY HARD BONE AND THE SURGEON DID NOT TAP THE BONE AS THEY NORMALLY WOULD IN THIS CASE. THE GRAFT ENDED UP WELL-FIXED, ALBEIT BY A SHORTER PIECE OF SCREW, AND THE SURGEON STATED TO THE REP THAT THEY SHOULD HAVE TAPPED THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961318 ↗
• InjuryFeb 19, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A BONE-TENDON-BONE (BTB) SURGERY WHEN INSERTING THE BIO-COMP INTERFERENCE SCREW INTO THE FEMORAL, THE TIP BROKE-OFF. THE SURGEON WAS NOT ABLE TO RETRIEVE IT, SO IT WAS LEFT IN THE JOINT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 29-JAN-2019: THE BROKEN FRAGMENT IS SCREWED TIGHT IN THE JOINT. IT CANNOT MOVE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8349398 ↗
• InjuryNov 15, 2018Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE SURGEON WAS ATTEMPTING TO INSERT A BIO-COMPOSITE INTERFERENCE SCREW, AR-1370C, AND UPON INSERTION, THE SCREW BROKE LEAVING ABOUT 5MM OF THE SCREW IN THE PILOT HOLE. A SECOND BIO-COMPOSITE INTERFERENCE SCREW OF THE SAME LOT WAS OPENED TO BE USED. THE SURGEON TAPPED THROUGH THE FIRST BROKEN SCREW FRAGMENT IN AN ATTEMPT TO SECURE THE FRAGMENT HOWEVER, THE SECOND SCREW BROKE AS WELL AT THE SAME LENGTH. 5MM OF THE SECOND SCREW WAS ALSO LEFT IN THE PATIENT IN THE SAME PILOT HOLE. THE SURGEON DECIDED TO CREATE A SECOND INCISION OVER THE FEMUR AND INSERTED A BUTTON TO SECURE FIXATION INSTEAD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8074663 ↗
• InjuryJun 14, 2018Material Fragmentation

  IT WAS REPORTED THAT HE SCREW BROKE WHEN IT WAS IMPLANTED, A PART REMAINS IN THE KNEE. NO FURTHER DETAILS OBTAINED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7600206 ↗
• InjuryJan 20, 2017Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE 7 MM X 23 MM BIOCOMPOSITE INTERFERENCE SCREW AR-1370C ((B)(4)) ALONG WITH THE 11 MM X 28 MM ROUND DELTA BIOCOMPOSITE INTERFERENCE SCREW AR-5028C-11((B)(4)), AND THE 10 MM X 28 MM ROUND DELTA BIOCOMPOSITE SCREW AR-5028C-10 ((B)(4)) WERE BEING USED IN AN ACL RECONSTRUCTION PROCEDURE. DURING THE PROCEDURE, WHILE TRYING TO IMPLANT THE 11 MM X 28 MM BIOCOMPOSITE SCREW INTO THE TIBIA, THE SCREW WOULD NOT COME OFF OF THE DRIVER. THIS WAS REMOVED FROM THE PATIENT SINCE IT WAS STILL STUCK ON THE DRIVER. THE 10 MM X 28 MM BIOCOMPOSITE CORKSCREW WAS OPENED FOR USE, HOWEVER IT WAS OPENED INCORRECTLY FROM THE PACKAGE, AND WAS DISCARDED. THE 7 MM X 23 MM BIOCOMPOSITE INTERFERENCE SCREW (AR-1370C) WAS OPENED FOR THE PROCEDURE. WHILE THE SURGEON WAS PASSING GRAFT THROUGH THE TIBIA, A PIECE OF BONE BLOCK BROKE OFF. THIS CAUSED THE SURGICAL TECHNIQUE TO BE CHANGED FROM BTB TO SOFT TISSUE WITH RT TIGHTROPE IN THE FEMUR. AN UNPLANNED INCISION WAS CREATED ON THE LATERAL SIDE OF THE FEMUR TO COMPLETE THE NEW SURGICAL TECHNIQUE SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6267715 ↗
• InjuryOct 14, 2016Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A DOUBLE BUNDLE PCL PROCEDURE, THE SURGEON ATTEMPTED TO LOAD TWO AR-1360C BIO-COMP INTERFERENCE SCREWS, LOT 1240135 ((B)(4)), ON THE DRIVER BUT NEITHER WOULD ATTACH TO THE DRIVER. THE SURGEON THEN OPENED AN AR-1370C, BIO-COMP INTERFERENCE SCREW, LOT 1216490 ((B)(4)), AND THE TIP OF THE AR-1370C BROKE-OFF INTO THE BONE TUNNEL. THE SURGEON REMOVED THE SCREW TIP AS BEST HE COULD BY DRILLING IT WITH A GUIDE PIN. IT IS POSSIBLE SOME FRAGMENTS REMAINED IN THE BONE TUNNEL. IN THE PROCESS OF REMOVING THE SCREW, THE GRAFT WAS DAMAGED AND EVENTUALLY TORE IN HALF WHEN PLACING A SECOND AR-1370C FROM SAME LOT. THIS SECOND AR-1370C WAS LEFT IN THE TUNNEL. TO COMPLETE THE CASE THE SURGEON OPENED TWO AR-1360C-CP KITS, LOT 10048527 AND LOT 300520. SURGEON USED THE 6X23 SCREWS FROM THE KITS AND ENDED UP USING ONE BUNDLE OF THE DOUBLE BUNDLE GRAFT INSTEAD OF TWO TO COMPLETE THE CASE SINCE THE OTHER WAS DAMAGED.

  Patient problems: No Information

  MAUDE report 6030724 ↗