Arthrex® AR-16991Recalls & reported problems
Arthrex, Inc. · Hip Labral Scorpion · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867184312), received between Apr 10, 2019 and Jun 13, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close1
- Improper or Incorrect Procedure or Method1
- Positioning Failure1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem
ON 05/19/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-16991 HIP LABRAL SCORPION WAS BEING UTILIZED FOR AN ARTHROSCOPIC HIP LABRAL REPAIR UTILIZING KNOTLESS FIBERTAK ANCHORS. THE SUTURE FELL OUT OF THE TOP JAW 3 TIMES, MISFIRED TWICE, AND CUT THE REPAIR STITCH UPON PASSING TWICE. THE DEVICE WAS CHANGED OUT WITH A NEW DEVICE (KEEPING THE SAME NEEDLE) AND WERE ABLE TO PUT IN 3 SUBSEQUENT ANCHORS WITHOUT ISSUE. THERE IS AN ISSUE WITH THE TOP JAW OF THE SCORPION CAUSING IT TO LIMIT ITS FUNCTION. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202779 ↗InjuryApr 10, 2019Improper or Incorrect Procedure or Method; Difficult to Open or Close
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO OPEN THE JAW OF THE SCORPION CORRECTLY DURING A HIP-ASK-LABRUM SURGERY, OUT OF THE JOINT IT WAS POSSIBLE TO OPEN THE SCORPION. IT WAS NOT POSSIBLE TO FINISH THE SURGERY SUCCESSFULLY SO A SECOND SURGERY WILL BE NECESSARY. THE DATE FOR THE SECOND SURGERY IS NOT KNOWN AT THE MOMENT. UPDATE 01-APR-19: ACCORDING TO THE CUSTOMER, THE SCORPION WORKS FINE OUTSIDE THE PATIENT. AS SOON AS IT WAS IN THE PATIENT THE JAW DID NOT OPEN ANY MORE. THE SURGEON CONFIRMED IT WAS HIS ERROR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8500364 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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