DUROGRIP BM067RRecalls & reported problems
Aesculap AG · HEGAR-MAYO DUROGRIP TC Needleholder, straight, 8", (205 mm), with 0.5 mm pitch of serration, suture up to 3/0, non-sterile, reusable · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653028276), received between Nov 2, 2021 and Nov 2, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2021Material Fragmentation; Material Fragmentation
CLARIFICATION WAS RECEIVED: THERE WAS NO DELAY CAUSED BY THE BREAKAGE IN THE ORIGINAL SURGERY. HOWEVER, POSTOPERATIVELY, THE PATIENT UNDERWENT ANOTHER PROCEDURE (NO SPECIFIED), AS WELL AS ATTENDING MULTIPLE PHYSICIAN APPOINTMENTS, AND REQUIRED THE PERFORMANCE OF ADDITIONAL X-RAYS.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 12740003 ↗InjuryNov 2, 2021Break; Break
CLARIFICATION WAS RECEIVED: THERE WAS NO DELAY CAUSED BY THE BREAKAGE IN THE ORIGINAL SURGERY. HOWEVER, POSTOPERATIVELY, THE PATIENT UNDERWENT ANOTHER PROCEDURE (NOT SPECIFIED), AS WELL AS ATTENDING MULTIPLE PHYSICIAN APPOINTMENTS, AND REQUIRED THE PERFORMANCE OF ADDITIONAL X-RAYS.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 12739301 ↗
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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