AESCULAP FF905SBRecalls & reported problems
Aesculap AG · CASPAR DISTR PIN16MMSTER · 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 04038653364336), received between Aug 11, 2022 and Aug 11, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (2 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.
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO AESCULAP INC. THAT A CASPAR DISTR PIN16MMSTER (PART # FF905SB) WAS USED DURING AN ANTERIOR CERVICAL FUSION PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE PRODUCT "FAILED." REPORTEDLY, THE DEVICE BROKE AND PIECES DETACHED INTO THE PATIENT. THE PIECES WERE RETRIEVED, AND THEN THE PROCEDURE WAS ABLE TO BE CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED; BROKEN PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15212190 ↗InjuryAug 11, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FF905SB - CASPAR DISTR PIN16MMSTER. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRODUCT "FAILED." THIS OCCURRED DURING AN ANTERIOR CERVICAL FUSION PROCEDURE. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED; BROKEN PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15212178 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page