Arthrex® AR-18700-49Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867317987), received between Dec 27, 2021 and Jul 11, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Break

  ON (B)(4) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-49 LOBSTER CLAMP, RADIOLUCENT HAD AN ISSUE. USING THE MINI CFS SET FOR A 5TH MET PROCEDURE ON (B)(6) 2022, THE SURGEON ASKED FOR THE AR-18700-49 LOBSTER CLAMP AND STARTED APPLYING PRESSURE TO CLAMP THE BONE, AND ONE SIDE OF THE CLAMP BROKE OFF. THE PIECE WAS RETRIEVED FROM THE PATIENT. THE REP OBSERVED THE SURGEON PERFORMING THE PROCEDURE AND HE SAID THAT HE WAS NOT APPLYING EXCESSIVE FORCE TO THE CLAMP. AN ALTERNATE CLAMP FROM THE SET WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PIECE THAT BROKE OFF WAS DISCARDED BY THE HOSPITAL, THE OTHER PIECE WAS AVAILABLE FOR RETURN. IT LOOKED LIKE THE ITEM FELL APART AND DID NOT BREAK DUE TO NEGLECT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976691 ↗
• MalfunctionJul 5, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-18700-49 LOBSTER CLAMP WAS BEING USED IN AN UNKNOWN CASE TO REDUCE THE FRACTURE, AND ONE OF THE TIPS BROKE-OFF. THE FRAGMENT WAS RETRIEVED. THE CASE WAS COMPLETED, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915064 ↗
• MalfunctionFeb 28, 2022Break; Material Deformation

  ON 02/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-49 LOBSTER CLAMP BROKE MID CASE, THE DEVICE WAS WARPED AND WHEN THE DOCTOR TRIED TO MANIPULATE IT, THE INSTRUMENT BROKE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621176 ↗
• MalfunctionJan 4, 2022Break; Degraded

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-49, THE PLASTIC LOBSTER CLAWS SNAPPED, AND THE AR-18700-25 SCREW FROM THE HOLDING SLEEVE RUSTED THROUGH. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. REQUESTED ADDITIONAL INFORMATION 12/15/2021. ON 12/15/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THE PLASTIC LOBSTER CLAW WASN¿T CLAMPING AND WAS FALLING APART DURING USE. THE SCREW RETENTION SLEEVE FALL INTO TWO PIECES. THE CASE WAS ON (B)(6) WITH DR. (B)(6) FINGER FRACTURE. THE CASE WAS COMPLETED USING JUST AN EXTERNAL FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154695 ↗
• MalfunctionDec 27, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-18700-49 CLAMP, AND A AR-18700-25 SLEEVE ARE BROKEN. THIS OCCURRED ON (B)(6) 2021 DURING A PROCEDURE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087978 ↗