Arthrex® AR-2271Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867026605), received between Apr 20, 2018 and Apr 23, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED ON 09/06/2022 BY A CUSTOMER VIA EMAIL THAT AN AR-2271 DOG BONE SYSTEM HAS DISPLACED AND REQUIRES A REVISION SURGERY. THIS WAS DISCOVERED AFTER USE. REVISION SURGERY SCHEDULED FOR (B)(6) 2022. REVISION SURGERY POSTPONED TO A LATER DATE. PER FACILITY: " PATIENT HAD SURGERY UNDER MY CARE TO RECONSTRUCT HIS ACJ ON (B)(6) 2022. AN ARTHROSCOPICALLY ASSISTED RECONSTRUCTION USING THE ARTHREX TIGHT ROPE/ DOG BONE TECHNIQUE WAS USED. SURGERY WAS UNEVENTFUL AND POST OPERATIVE X-RAYS SHOWED A GOOD POSITION OF THE DOG BONE BUTTONS AND AN EXCELLENT REDUCTION OF THE ACJ. THE PATIENT WAS KEPT IN A SLING FOR 6 WEEKS AS PER THE MANUFACTURERS RECOMMENDATION ALLOWING ASSISTED RANGE OF MOTION EXERCISES OF THE SHOULDER. ACTIVE PHYSIOTHERAPY EXERCISES WAS STARTED AFTER THIS. THE REDUCTION OF THE ACJ AT THE SIX WEEK MARK WAS STILL EXCELLENT ALTHOUGH A FEW MILLIMETRES OF LOSS OF REDUCTION WAS NOTED. HIS POST OPERATIVE RECOVERY WAS UNEVENTFUL AND HE REGAINED FULL RANGE OF MOTION OF HIS SHOULDER WITH THE AID OF THE PHYSIOTHERAPIST. HE WAS DISCHARGED FROM MY CLINIC ON (B)(6) 2022 WHEN POST OPERATIVE X-RAYS SHOWED A WELL MAINTAINED REDUCTION. IN LATE AUGUST HE NOTED AN INCREASES DEFORMITY OF TH

  Patient problems: Failure of Implant

  MAUDE report 19164183 ↗
• MalfunctionOct 20, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE REPAIR SYSTEM SUTURE FROM AN AR-2271 ACUTE AC REPAIR IMPLANT SYSTEM BROKE DURING IMPLANTATION. ANOTHER AR-2271 ACUTE AC REPAIR IMPLANT SYSTEM WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN AC JOIN RECONSTRUCTION PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17974518 ↗
• InjuryMar 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2022 BY A CUSTOMER VIA EMAIL THAT AN AR-2271 DOG BONE SYSTEM HAS DISPLACED AND REQUIRES A REVISION SURGERY. THIS WAS DISCOVERED AFTER USE, REVISION PLANNED FOR (B)(6) 2022. UPDATED REVISION SURGERY RESCHEDULED TO (B)(6) 2022. PER FACILITY: "PATIENT HAD AN ACUTE GRADE 3 DISRUPTION OF HIS ACJ ON (B)(6) 2022 FOLLOWING A FALL OFF OF HIS BIKE. HE HAD SURGERY UNDER MY CARE TO RECONSTRUCT HIS ACJ ON (B)(6) 2022. AN ARTHROSCOPICALLY ASSISTED RECONSTRUCTION USING THE ARTHREX TIGHT ROPE/ DOG BONE TECHNIQUE WAS USED. SURGERY WAS UNEVENTFUL AND POST OPERATIVE X-RAYS SHOWED A GOOD POSITION OF THE DOG BONE BUTTONS AND AN EXCELLENT REDUCTION OF THE ACJ. THE PATIENT WAS KEPT IN A SLING FOR 6 WEEKS AS PER THE MANUFACTURER'S RECOMMENDATION AND ACTIVE PHYSIOTHERAPY EXERCISES WHERE STARTED AT THIS STAGE. THE REDUCTION OF THE ACJ AT THE SIX-WEEK MARK WAS STILL EXCELLENT ALTHOUGH A FEW MILLIMETERS OF LOSS OF REDUCTION WAS NOTED. AT SIX WEEKS POST-SURGERY, ONCE THE REDUCTION IS WELL MAINTAINED, AS IS MY NORMAL PRACTICE, THE PATIENT WAS DISCHARGED FROM MY CARE AND LEFT IN THE HANDS OF THE THERAPIST. THIS VISIT OCCURRED ON (B)(6) 2022. PATIENT WAS ADVISED ON ACTIVE RANGE OF MOTION

  Patient problems: Failure of Implant

  MAUDE report 16597087 ↗
• MalfunctionJul 11, 2022Break

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR (AC) REPAIR SURGERY THE WIRE OF THE DEVICE BROKE OFF. THE BROKEN OFF PART WAS 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. ACCORDING TO THE PROVIDED INFORMATION A SECOND SURGERY WAS REQUIRED. UPDATE 01-JUL-2022: IT WAS CONFIRMED THAT NO REVISION SURGERY WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978518 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT EXPERIENCED AN INFECTION AFTER HAVING ARTHREX PARTS IMPLANTED. AT THE TIME OF THE CALL THE FACILITY REPORTER WAS LOOKING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE IMPLANTS, AND DID NOT HAVE ANY OTHER AVAILABLE INFORMATION OTHER THAN THE ARTHREX PARTS THAT WERE USED IN THE ORIGINAL PROCEDURE. THE FOLLOWING ARTHREX PARTS WERE USED DURING THE ORIGINAL PROCEDURE: AR-2271 // LOT: F185810. AR-7209T . AR-2275. ADDITIONAL INFORMATION OBTAINED 5/30/2019: THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2019. THE PROCEDURE WAS A RIGHT SHOULDER OPEN ARTHROTOMY ACROMIOCLAVICULAR JOINT, ACROMIOCLAVICULAR DISLOCATION REPAIR AND JOINT INJECTION. THE PATIENT BEGAN EXPERIENCING SYMPTOMS SIX WEEKS POST-OP. THE PATIENT UNDERWENT A SURGICAL WOUND WASHOUT (DATE UNKNOWN) AND WAS TREATED WITH IV ANTIBIOTICS AND PROGRESSED TO ORAL ANTIBIOTICS. SINUS TRACK DRAINAGE WAS DONE AND A PICO DRESSING WAS PLACED. ONE WEEK LATER THE WOUND WAS SUTURED CLOSED AND THE ISSUES ARE RESOLVING. CULTURES WERE DONE ON (B)(6) 2019 AND THE PATIENT WAS FOUND TO HAVE PROPIONIBACTERIUM. ADDITIONAL INFORMATION OBTAINED 6/4/19: THE SURGICAL WOUND WASHOUT WAS PERFORMED ON (B)(6) 2019. T

  Patient problems: Unspecified Infection

  MAUDE report 8636988 ↗
• InjuryApr 20, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY PATIENT THAT ON (B)(6) 2016 HE HAD A RIGHT AC RECONSTRUCTION INVOLVING AN ARTHREX TIGHTROPE AND DOG BONE BUTTON, WHICH WAS PERFORMED AT ONE FACILITY. PATIENT STATED HIS CLAVICLE POPPED OUT AGAIN AND IN (B)(6) 2016 HE UNDERWENT A REVISION PROCEDURE, WHICH WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. PATIENT ALSO STATED THAT DURING THE REVISION THE FIBERTAPE WAS FOUND TO BE RIPPED AND THE METAL DOG BONE BUTTON WAS EMBEDDED IN THE BONE. NO FURTHER INFORMATION WAS AVAILABLE FROM PATIENT AT TIME OF INITIAL REPORT. FOLLOW-UP INVESTIGATION: PATIENT HAS PROVIDED MEDICAL RECORDS AND PART NUMBER. PATIENT STATES HE SUSTAINED AN INFECTION AFTER SURGERY AND APPROXIMATELY ONE MONTH POST SURGERY WAS IN A LOT OF PAIN AND NOTICE BONE PROTRUDING AS IT HAD BEFORE SURGERY. PATIENT FOLLOWED UP WITH REGULAR SURGEONS WHO RECOMMENDED WAITING TO SEE IF THE AREA HEALED. PAIN CONTINUED AND HE SOUGHT A SECOND OPINION. THE SECOND OPINION SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2016. PATIENT STATES SINCE REVISION HE STILL HAS PAIN IN SHOULDER THAT RADIATES DOWN ARM AND FINGERS. PATIENT CANNOT SLEEP ON HIS RIGHT SIDE. PATIENT STATES PAIN TRIGGERS HEADACHES. PATIENT STAT

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7447388 ↗