SHARP HOOK
Received Apr 1, 2015
Report 9680938-2015-10034 · MDR key 4650069
Device
Generic name
Hook,surgical,gen & Plastic Surgery
Manufacturer
Synthes TuttlingenCatalog number
319.39.96
Lot number
A7MA18
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE SALES CONSULTANT THAT A SHARP HOOK, PART # 319.39.96 , LOT # A7MA18, BROKE OFF DURING SURGERY. IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).
Additional Manufacturer Narrative
DDEVICE HISTORY RECORDS WAS ATTEMPTED. THE REPORT INDICATES THAT THE MANUFACTURING DATE: APRIL 30TH, 2003, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE RECORDS COULD NOT BE IDENTIFIED DUE TO THE AGE OF THE INSTRUMENT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSISIF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE: EVENT DATE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.