DUROGRIP MAYO-HEGAR NEEDLE HOLDER 185MM
Received Jun 12, 2025 · Event occurred Jun 10, 2025
Report 9610612-2025-00110 · MDR key 22198154
Device
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BM066R - DUROGRIP MAYO-HEGAR NEEDLE HOLDER 185MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS A POSSIBLE METAL FRAGMENT THAT REMAINED IN SITU. THE DEVICE TIP WAS NOTED AS "CHIPPED" FOLLOWING AN UNSPECIFIED SURGERY. AN X-RAY RESULT SHOWED WHAT MIGHT BE A FRAGMENT; THE SURGEON STATED THAT IT WOULD NOT BE REMOVED FROM THE PATIENT'S BODY. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THEREFORE, THE INVESTIGATION WAS BASED ON EVENT DESCRIPTION. BATCH HISTORY REVIEW: A BATCH HISTORY REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER COULD NOT BE IDENTIFIED. EVEN FAITHFUL ATTEMPTS FOR RETRIEVAL, NO FURTHER INFORMATION COULD BE RECEIVED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON THE REVIEW OF THE APPLICABLE RISK ANALYSIS. CONCLUSION/ PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION AND WITHOUT THE PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.