DUROGRIP BM022RRecalls & reported problems
Aesculap AG · HEGAR-MAYO-SEELEY DUROGRIP TC Needleholder, straight, 8", (205 mm), with 0.4 mm pitch of serration, suture 4/0 - 6/0, 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 04038653028009), received between Nov 7, 2021 and Nov 7, 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.
InjuryNov 7, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BM022R - TC HEGAR-MAYO-SEELEY NEEDLE HOLDER205MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CARBIDE TIP WAS BROKEN. DURING THE SURGERY, THE CARBIDE TIP WAS DAMAGED BY ABOUT 5 X 3 MM ON THE ROOT SIDE, RESULTING IN A RESIDUAL EVENT IN THE BODY. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12763165 ↗
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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