Arthrex® AR-3670Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00888867305427), received between Jan 20, 2020 and Sep 2, 2026 — classified as 3 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (21 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Physical Resistance/Sticking

  Patient problems: Insufficient Information

  MAUDE report 50565480 ↗
• MalfunctionSep 2, 2026Failure to Advance

  Patient problems: Insufficient Information

  MAUDE report 50564388 ↗
• MalfunctionFeb 11, 2026Break

  ON 23-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3670 FIBERTAK TIP OF THE INSERTER BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. FRAGMENT WAS REMOVED. NO DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314794 ↗
• MalfunctionFeb 5, 2026Physical Resistance/Sticking

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3670 FIBERTAK BICEPS IMPLANT SET EXPERIENCED AN ISSUE DURING USE. WHILE ATTEMPTING TO PULL THE DRILL OUT OF THE DRILL GUIDE, THE DRILL BECAME STUCK AND WOULD NOT DISENGAGE FROM THE SLEEVE. AFTER THE DRILL AND GUIDE WERE PLACED ON THE BACK TABLE, THE SCRUB TECHNICIAN OBSERVED THAT THE MOLDED PLASTIC HAD BOUND AROUND THE DRILL, PREVENTING REMOVAL. IT WAS ALSO REPORTED THAT PRIOR TO DRILLING, THE SCRUB TECHNICIAN ENGAGED THE POWER TO ENSURE THE DRILL WAS NOT WOBBLING, AND NO WOBBLING WAS OBSERVED. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 19-JAN-2026: THIS OCCURRED DURING A BICEPS TENODESIS PROCEDURE. THE FIBERTAK ANCHOR WAS NOT IMPLANTED. NO BREAKAGE OCCURRED INSIDE THE PATIENT, AND NO FRAGMENTS WERE PRESENT OR REQUIRED RETRIEVAL. THE CASE WAS COMPLETED USING AN AR-3671DS FIBERTAK BICEPS DISPOSABLES KIT. THERE WAS NO SURGICAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267207 ↗
• MalfunctionJan 22, 2026Break

  ON 07-JAN-2026, AN FDA MEDSUN NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING A LEFT KNEE DIAGNOSTIC ARTHROSCOPY WITH OPEN POSTERIOR CRUCIATE LIGAMENT REPAIR AND MEDIAL COLLATERAL LIGAMENT REPAIR AND RECONSTRUCTION USING SEMITENDINOSUS AUTOGRAFT, A SMALL FRAGMENT, APPROXIMATELY A 1 MM TINE FROM THE INSERTER OF AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM, BROKE OFF WITHIN THE SURGICAL SITE DURING PASSAGE. THE FRAGMENT WAS NOT RETRIEVED AND WAS LEFT IN THE PATIENT DUE TO ITS SIZE AND INABILITY TO BE DETECTED UNDER FLUOROSCOPY. THE SURGEON DETERMINED THAT RETRIEVAL POSED MORE RISK THAN BENEFIT AND EXPRESSED NO CONCERNS REGARDING PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED ON 13-JAN-2026: THIS EVENT OCCURRED ON 01-DEC-2025. THE CASE WAS COMPLETED USING THREE ARTHREX DOUBLE-LOADED 1.8 MM SOFT SUTURETAK ANCHORS, WHICH REMAINED STABLE AFTER IMPLANTATION. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24146332 ↗
• MalfunctionDec 29, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 12/08/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3670 FIBERTAK® BICEPS IMPLANT SYSTEM DRILL TWISTED DURING A BICEPS TENODESIS PROCEDURE. THE ISSUE OCCURRED AS SOON AS THE DRILL MADE CONTACT WITH THE BONE. NO DEBRIS OR FRAGMENTS WERE GENERATED, AND THE PATIENT WAS NOTED TO HAVE GOOD HARD BONE QUALITY. THE CASE CONTINUED USING A SECOND AR-3670 FIBERTAK® BICEPS IMPLANT SYSTEM, RESULTING IN APPROXIMATELY A ONE-MINUTE DELAY THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906781 ↗
• MalfunctionDec 1, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3670 FIBERTAK BICEPS IMPLANT SET CANNULATION OF THE DRILL SLEEVE WAS NARROW, WHICH CAUSED THE DRILL BIT TO BE BOUND UPON USE AND THEREFORE UN-USEABLE TO CREATE A SUFFICIENT DRIP HOLE FOR IMPLANT INSERTION. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687303 ↗
• MalfunctionDec 1, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON 11/07/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT WHEN USING THE AR-3670 FIBERTAK BICEPS IMPLANT SET, PER THE CORRECT SURGICAL TECHNIQUE, THE CANNULATION OF THE BLUE DRILL SLEEVE WAS TOO SMALL TO ACCEPT THE COMPATIBLE DRILL, CAUSING IT TO BIND AND, THEREFORE, PREVENTING THE SURGEON FROM PREPARING THE IMPLANT SITE APPROPRIATELY. A NEW ITEM WAS OPENED TO COMPLETE THE DISTAL BICEPS REPAIR SAFELY. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680313 ↗
• MalfunctionNov 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT THE GUIDE COMPONENT FROM THE AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM BECAME COLD-WELDED TO THE DRILL DURING USE. THE ISSUE OCCURRED WHILE DRILLING INTO THE ELBOW. NO COMPONENTS FRACTURED, AND NO DEBRIS WAS GENERATED. THE SURGEON WAS ABLE TO REMOVE BOTH THE DRILL AND GUIDE WITHOUT COMPLICATION AND PROCEEDED TO COMPLETE THE PROCEDURE USING A REPLACEMENT AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM. THE EVENT RESULTED IN A DELAY OF APPROXIMATELY TWO MINUTES. IT IS UNCLEAR WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING A TRICEPS REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643361 ↗
• MalfunctionOct 15, 2025Use of Device Problem; Use of Device Problem

  Patient problems: Insufficient Information

  MAUDE report 23291100 ↗
• MalfunctionSep 19, 2025Device Damaged by Another Device; Excessive Heating; Device Damaged by Another Device; Excessive Heating

  ON 09/02/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3670 FIBERTAK® BICEPS IMPLANT SYSTEMS HEATED AND MELTED/LENGTHENED THE DEVICE. THIS OCCURRED DURING A DISTAL BICEPS PROCEDURE, THE BLUE DRILL GUIDES, METAL END FUSED WITH THE DRILL BIT, THE SECOND DEVICE'S CANNULATION OF THE DRILL GUIDE HEATED UP AND LENGTHENED. THE CASE WAS COMPLETED USING ONE OF THE DEVICES, AND THE ANCHOR WAS PUT IN. THE CASE WAS DELAYED ABOUT 25 MINUTES. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100847 ↗
• MalfunctionSep 19, 2025Melted; Device Damaged by Another Device; Melted; Device Damaged by Another Device

  ON 09/02/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3670 FIBERTAK® BICEPS IMPLANT SYSTEMS HEATED AND MELTED/LENGTHENED THE DEVICE. THIS OCCURRED DURING A DISTAL BICEPS PROCEDURE, THE BLUE DRILL GUIDES, METAL END FUSED WITH THE DRILL BIT, THE SECOND DEVICE'S CANNULATION OF THE DRILL GUIDE HEATED UP AND LENGTHENED. THE CASE WAS COMPLETED USING ONE OF THE DEVICES, AND THE ANCHOR WAS PUT IN. THE CASE WAS DELAYED ABOUT 25 MINUTES. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100820 ↗
• MalfunctionAug 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BICEPS SURGERY THE DRILL WAS STUCK IN THE DRILL GUIDE AND THE DEVICE WAS IMPOSSIBLE TO BE REMOVED. 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 22882744 ↗
• MalfunctionJul 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM ENCOUNTERED AN ISSUE DURING USE. WHILE DRILLING, THE DEVICE ENCOUNTERED HEAVY RESISTANCE, AND THE DRILL BECAME LODGED WITHIN THE GUIDE. IT COULD NOT BE REMOVED UNTIL IT WAS REMOVED FROM THE SURGICAL FIELD. UPON INSPECTION, THE METAL SLEEVE APPEARED MISALIGNED AND NOT CENTERED WITHIN THE DRILL GUIDE. THIS WAS DISCOVERED DURING A TRICEPS REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/08/2025: THE CASE WAS COMPLETED USING A SECOND AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM. A MINIMAL DELAY OCCURRED, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO INSTRUMENT OR IMPLANT BREAKAGE WAS OBSERVED DURING THE EVENT, AND NO DEBRIS WAS PRODUCED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575775 ↗
• MalfunctionJul 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 16TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3670, FIBERTAK® BICEPS IMPLANT SYSTEM, THE DRILL BIT WELDED TO THE DRILL GUIDE AND WAS UNABLE TO BE REMOVED. THEY TRIED TO USE A KOCKER TO HOLD THE DRILL BIT BUT IT DID NOT WORK. THEY ALSO TRIED TO USE A MALLET TO BACK IT OUT BUT IT DID NOT WORK. THIS WAS DETECTED DURING USE IN A LATERJET PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER DRILL GUIDE WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 22508753 ↗
• MalfunctionJun 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN OPEN PROXIMAL BICEPS REPAIR SURGERY BOTH ANCHORS REFUSED TO DEPLOY. SECOND DRILL HILD MADE, BUT SAME ISSUE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE AR-3632SP-1. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148741 ↗
• MalfunctionMay 15, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE WIRE WAS INSERTED IN THE GUIDE AND WHEN PULLING THE WIRE IT WAS NOT ANCHORED. 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 22024554 ↗
• MalfunctionMay 14, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 5/15/2025: THIS WAS DISCOVERED WHILE THE FIBERTAK WAS IN THE PATIENT DURING AN MCL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE ANCHOR WAS REMOVED, AND NO FRAGMENTS REMAINED INSIDE THE PATIENT. THE CASE WAS COMPLETED USING AN AR-3633SP SELF-PUNCHING FIBERTAK. THE CASE EXPERIENCED A BRIEF DELAY OF A FEW MINUTES BUT PROCEEDED WITHOUT THE NEED FOR ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019570 ↗
• MalfunctionMay 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/15/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM HAD THE DRILL BOUND UP AND DID NOT FIT DOWN THE GUIDE WELL WHEN DRILLING. AS SHOWN IN THE PHOTO THROUGH THE SLOTTED DRILL GUIDE, THE PLASTIC HAS BECOME STUCK AND HAS EVEN BEGUN TO MELT DUE TO FRICTION. THE PATIENT WAS NOT HARMED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001793 ↗
• MalfunctionApr 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4), AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM MALFUNCTIONED DURING USE. WHILE DRILLING FOR THE FIBERTAK ANCHOR, THE DRILL BIT BECAME LODGED IN THE DRILL GUIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM, WITH NO REPORTED CASE DELAY. FOLLOWING THE PROCEDURE, THE SURGEON WAS ABLE TO EXTRACT THE DRILL BIT FROM THE DRILL GUIDE USING PLIERS. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901964 ↗
• MalfunctionApr 1, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 03/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE METAL 1.9 DRILL COLD WELDED TO THE INNER METAL DRILL SLEEVE FROM AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM. THE BLUE PLASTIC SHEATH ALSO SLID OFF. THIS WAS DISCOVERED DURING AN OPEN PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21741139 ↗
• MalfunctionFeb 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 2/13/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM HAD AN ISSUE. DURING A SUBPECTORAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WHEN THE SURGEON WAS USING THE DRILL GUIDE, HE STATED THAT AT THE VERY DISTAL TIP OF THE DRILL GUIDE, IT FELT LIKE A VERY SNUG FIT AND THAT THE DRILL SEEMED TOO BIG FOR THE DRILL GUIDE. WHEN TRYING TO DRILL INSIDE THE PATIENT, THE DRILL GOT STUCK INSIDE THE DRILL GUIDE. BOTH DEVICES WERE STUCK TOGETHER AND REMOVED FROM THE PATIENT IN ONE PIECE. NOTHING BROKE INSIDE THE PATIENT, NO DEBRIS WAS PRODUCED, AND THERE WAS NO HARM TO THE PATIENT. THE COMPLAINT DEVICES WERE DISCARDED. ANOTHER AR-3671DS FIBERTAK BICEPS DISPOSABLES KIT WITH AN UNKNOWN LOT NUMBER WAS OPENED AND USED WITH THE FIBERTAK DOUBLE-LOADED ANCHOR FROM THE AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A 3-MINUTE CASE DELAY REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468958 ↗
• MalfunctionDec 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE NEEDLES FROM AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM FELL OFF BEFORE THE IMPLANT WAS DEPLOYED. THIS WAS DISCOVERED DURING A PROXIMAL SUB PEC BICEP TENODESIS PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING THE FREE NEEDLE PROVIDED IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917180 ↗
• InjuryOct 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT SHE WAS EXPERIENCING PAIN AND INFLAMMATION POST-OPERATIVELY AND INQUIRED ABOUT THE MATERIAL COMPOSITION OF SEVERAL KNOWN AND UNKNOWN ARTHREX PRODUCTS. DURING AN INITIAL ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, QTY. 2 OF AN AR-2324BCM SUTURE ANCHOR, BIO-COMPOSITE SWIVELOCK SP, AN AR-3633SP FIBERTAK SP SUTURE ANCHOR, AND AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM WERE IMPLANTED. AFTER 6 WEEKS POST-OP, THE PATIENT EXPERIENCED INCREASING PAIN AND INFLAMMATION, BUT THE INITIAL SURGEON DID NOT WANT TO PERFORM REVISION SURGERY AND STATED THAT NOTHING WAS WRONG. THE PATIENT THEN WENT TO ANOTHER SURGEON WHO PERFORMED REVISION SURGERY ON THE RIGHT SHOULDER ON (B)(6) 2024. IT WAS FOUND THAT THE SUTURES TO ONE OF THE ANCHORS WERE LOOSE; NOTHING HAD BROKEN INSIDE THE PATIENT. THE SURGEON CUT THE LOOSE SUTURES AND REMOVED THEM, BUT THE ANCHOR AND ALL OTHER DEVICES FROM THE INITIAL SURGERY REMAINED INSIDE THE PATIENT. DURING THE ADDITIONAL PROCEDURE, ADDITIONAL UNKNOWN ARTHREX SUTURE ANCHORS, SWIVELOCK ANCHORS, AND A GRAFT WERE IMPLANTED USING THE ARTHREX CUFFMEND SYSTEM. AFTER THE ADDITIONAL SURGERY, THE PATIENT EXPERIENCED PAIN AND

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20560439 ↗
• MalfunctionOct 3, 2024Mechanical Jam; Mechanical Jam

  ON 09/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM HAD THE DRILL GOT CAUGHT ON THE SLIT OF THE DRILL GUIDE. NOTHING BROKE INSIDE THE PATIENT, AND DEBRIS WAS PRODUCED ONLY ON THE OUTSIDE OF THE PATIENT. ANOTHER AR-3670 FIBERTAK BICEPS IMPLANT WAS USED FROM A DIFFERENT LOT WITH NO ISSUES. THERE WAS NO CASE DELAY. THIS WAS DISCOVERED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359466 ↗