AESCULAP BM154RRecalls & reported problems
Aesculap AG · MATHIEU DUROGRIP TC Needleholder, straight, 7 7/8", (200 mm), standard, with 0.5 mm pitch of serration, Mathieu type handle, Mathieutype ratchet, suture up to 3/0, non-sterile, reusable · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653028597), received between Oct 29, 2021 and Oct 29, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO AESCULAP AG THAT A TC MATHIEU NDL HLDRSTDGRIP/RCHT200MM (PART # BM154R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SPRING BROKE DURING SURGERY. THE LEAF SPRING OF THE MATHIEU NEEDLE HOLDER WAS DAMAGED DURING SURGERY. THE DAMAGED PART MAY NOT BE FOUND AND MAY REMAIN IN THE PATIENT'S BODY. THE PATIENT'S INFECTION IS UNKNOWN, BUT THE SAMPLE HAS BEEN DISINFECTED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PART POSSIBLY REMAINED IN THE BODY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4) REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12719757 ↗
Other HOLDER, NEEDLE; ORTHOPEDIC devices
- Sklar Instruments 96-2355ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar® 96-2587Sklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2358ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2591ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2583ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2581Sklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2585ASklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 reports
- Sklar Instruments 96-2586Sklar Corporation · HOLDER, NEEDLE; ORTHOPEDIC1 recall0 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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