Arthrex® AR-8950JDRecalls & reported problems
Arthrex, Inc. · MINI JOINT DISTRACTOR · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867054745), received between Jun 19, 2024 and Apr 18, 2025 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2025Use of Device Problem; Use of Device Problem
ON 04/02/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-8950JD MINI JOINT DISTRACTOR STOPPED WORKING. THIS OCCURRED IN A CASE ON (B)(6) 2025, WHEN THE RATCHETING MECHANISM ON THE DEVICE STOPPED WORKING. A DIFFERENT DISTRACTOR WAS BROUGHT IN TO COMPLETE THE CASE. NO ADVERSE REACTIONS TO THE PATIENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21865274 ↗MalfunctionOct 24, 2024Break; Break
ON 10/11/2024, A SALES REPRESENTATIVE VIA(B)(4) REPORTED THAT AN AR-8950JD MINI JOINT DISTRACTOR WAS BROKEN, AND NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EFFECTS FOR THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524556 ↗MalfunctionJun 19, 2024Break; Break
IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE THREADED PART BROKE WHEN THE SURGEON HAD OPENED THE DEVICE. IT WAS FURTHER REPORTED THAT NOTHING BROKE OFF AND THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19568138 ↗
Other Apparatus, traction, non-powered devices
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- Active Heel Traction Boot 72203270Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED20 reports
- NA 357.371Synthes GmbH · APPARATUS, TRACTION, NON-POWERED16 reports
- NA SD393.640Synthes GmbH · APPARATUS, TRACTION, NON-POWERED15 reports
- NA 394.44Synthes GmbH · APPARATUS, TRACTION, NON-POWERED12 reports
- Active Heel Traction Boot 72202682Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED10 reports
- Arthrex® AR-8970JDArthrex, Inc. · Apparatus, traction, non-powered10 reports
- NA 72201725Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.