SUTURE CROCHET HOOK
Received Sep 17, 2020 · Event occurred Sep 8, 2020
Report 0001825034-2020-03551 · MDR key 10546148
Device
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A CONTRIBUTING FACTOR COULD BE THE MENTION OF TOO MUCH PRESSURE, HOWEVER, THAT WAS UNABLE TO BE CONFIRMED AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
(B)(4). DEVICE PRODUCT CODE: GDG. UDI#: (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE END TIP OF THE SUTURE CROCHET HOOK WAS BROKEN DURING THE SURGERY. THE REASON WAS DUE TO MUCH PRESSURE. ANOTHER SUTURE INSTRUMENT WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.