Tecomet AR-9938-11Recalls & reported problems
Tecomet Inc. · WIRE CUTTER FRONT SIDE, 15° ANGLE TC, WITH SAFETY INSERTS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841435109582), received between Sep 11, 2024 and Jun 18, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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.
Reports received per month
Most reported problems
Device problems
- Break6
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Break; Break
ON 05/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER CLAMP BROKE. 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 22282404 ↗MalfunctionMay 21, 2025Break; Break
ON 05/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER W/ SAFETY INSERT BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062853 ↗MalfunctionApr 30, 2025Break; Break
ON 04/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-9938-11 .062 WIRE CUTTER WAS BROKEN. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO PIECES BROKE OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A TALAR OATS PROCEDURE ON 04/07/2025, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936834 ↗MalfunctionApr 18, 2025Break; Break
ON (B)(6) 2025 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER BROKE WHILE TRYING TO CUT THE SNAP OFF PINS. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21867056 ↗MalfunctionNov 19, 2024Break; Break
ON 10/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER BROKE. THIS OCCURRED DURING A CASE.
Patient problems: Insufficient Information
MAUDE report 20724008 ↗MalfunctionSep 11, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER BROKE. THIS OCCURRED DURING AN ORIF ANKLE PROCEDURE ON (B)(6) 2024 AFTER PLACING A SNAP-OFF COMPRESSION FT PIN, THE SURGEON TRIED TO CLIP THE REMAINING IMPLANT WITH THE PIN CUTTER AND THE PIN CUTTER BROKE.
Patient problems: Insufficient Information
MAUDE report 20188698 ↗
Other Cutter, Wire devices
- NA 03.607.513Synthes GmbH · CUTTER, WIRE35 reports
- NA 03.221.006Synthes GmbH · CUTTER, WIRE34 reports
- NA 388.72Synthes GmbH · CUTTER, WIRE29 reports
- NA 03.221.008Synthes GmbH · CUTTER, WIRE11 reports
- NA 391.93Synthes GmbH · CUTTER, WIRE9 reports
- NA 391.906Synthes GmbH · CUTTER, WIRE8 reports
- NA 391.771Synthes GmbH · CUTTER, WIRE8 reports
- NA 391.905Synthes GmbH · CUTTER, WIRE7 reports
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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