DUROGRIP BM026RRecalls & reported problems
Aesculap AG · DUROGRIP TC Needleholder, straight, 7 7/8", (200 mm), very delicate, with 0.2 mm pitch of serration, suture 6/0 - 10/0, non-sterilereusable · 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 04038653028047), received between Jun 7, 2024 and Jun 7, 2024 — 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.
Reports received per month
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.
InjuryJun 7, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO MEDWATCH USER FACILITY REPORT (B)(4): 1ST SURGERY [DATE REDACTED] - FOLLOWING AN OPEN VENTRAL HERNIA REPAIR, IT WAS IDENTIFIED THAT ONE OF THE NEEDLE DRIVERS USED IN THE FASCIAL CLOSURE OF THE ABDOMEN WAS BROKEN AT THE TIP OF THE INSERT. THE FIELD WAS SEARCHED FOR THIS SMALL PIECE. AT THE TIME IT WAS IDENTIFIED, THE FASCIA AND ABOVE WAS CLOSED. AN X-RAY WAS THEN OBTAINED. THE ATTENDING RADIOLOGIST READ THAT THERE WAS A 2 MM METALLIC DENSITY PROJECTING OVER THE RIGHT UPPER QUADRANT ON AP RADIO-GRAPH. ON LATERAL RADIOGRAPH, THE METALLIC DENSITY IS APPROXIMATELY 3.1 CM DEEP TO THE FASCIA AND 7.0 CM FROM THE SKIN SURFACE. IT WAS UNCLEAR IF THIS WAS IN THE PERITONEAL CAVITY OR IN THE EXTRAPERITONEAL SPACES WHICH WOULD DETERMINE THE OPERATIVE RISK OF RE-EXPLORATION. A CT OF THE ABDOMEN WAS OBTAINED TO HELP FURTHER LOCALIZE THE FRAGMENT AND IT WAS FOUND TO BE LIKELY IN THE RETRORECTUS SPACE. RISK AND BENEFITS DISCUSSION WERE HELD WITH THE PATIENT AND SHE ELECTED TO UNDERGO AN EXPLORATORY SURGERY TO REMOVE THE FOREIGN BODY. 2ND SURGERY 1 DAY LATER [DATE REDACTED]- THE SURGEON EXPLORED THE LATERAL UPPER SPACE OF THE RIGHT SIDE OF THE ABDOMEN NEAR THE NEUROVASCULAR BUNDLE IN THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19492908 ↗
Other HOLDER, NEEDLE; ORTHOPEDIC devices
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- 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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