CRANE PICK ELEVATOR

Additional Manufacturer Narrative

(B)(4). D10: CRANE PICK ELEVATOR CAT# 09-0262 LOT# K20, CRANE PICK ELEVATOR CAT# 09-0262 LOT# K20, CRANE PICK ELEVATOR CAT# 09-0262 LOT# D22, CRANE PICK ELEVATOR CAT# 09-0262 LOT# K21, CRANE PICK ELEVATOR CAT# 09-0262 LOT# K21, CRANE PICK ELEVATOR CAT# 09-0262 LOT# J20, ELEVATOR #77R CAT# 09-0313 LOT# G22, ELEVATOR #77R CAT# 09-0313 LOT# G22, ELEVATOR #77R CAT# 09-0313 LOT# B21, ELEVATOR #77R CAT# 09-0313 LOT# L19, ELEVATOR #77R CAT# 09-0313 LOT# L19, ELEVATOR #77R CAT# 09-0313 LOT# D19, ELEVATOR #77R CAT# 09-0313 LOT# D19, ELEVATOR #77R CAT# 09-0313 LOT# F19, EXODONTIA ELEVATOR #81 CAT# 09-0293 LOT# H19, EXODONTIA ELEVATOR #81 CAT# 09-0293 LOT# C18, MOLT PERIOSTEAL ELEVATOR #9 CAT# 09-0394 LOT# G19, MOLT PERIOSTEAL ELEVATOR #9 CAT# 09-0394 LOT# G19, MOLT PERIOSTEAL ELEVATOR #9 CAT# 09-0394 LOT# G19, MOLT PERIOSTEAL ELEVATOR #9 CAT# 09-0394 LOT# J21, ELEVATOR #1 CAT# 09-0259 LOT# C19. A VISUAL INVESTIGATION WAS CONDUCTED ON THE RETURNED INSTRUMENT. THE INSTRUMENT SHOWS SIGNS OF MULTIPLE USES INCLUDING VERY HEAVY MARKING AND SCRATCHING ON THE INSTRUMENT SURFACES. FURTHER INSPECTION SHOWS THAT THE ELEVATOR TIP HAS FRACTURED. THE FRACTURED TIP WAS NOT RETURNED. A DETERMINATION CANNOT BE MADE AS TO WHAT CAUSED THE ELEVATOR TO FRACTURE. A FRACTURE ANALYSIS WAS NOT CONDUCTED AS THE INSTRUMENT SHOWS SIGNS OF MULTIPLE USES. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED THROUGH PRODUCT RETURN. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE ELEVATOR WAS DISCOVERED TO BE WORN OVER TIME AND NEEDED REPLACING. NO SPECIFIC SURGERY OR PATIENT WAS INVOLVED, AND NO PATIENT HARM WAS REPORTED. INVESTIGATION OF THE RETURNED DEVICE HAS CONCLUDED THAT THE INSTRUMENT HAS A FRACTURED TIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.