MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER STANDARD 3.5 MM HEX; ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE

Catalog Number	00249003507
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product identified a znn cephalomedullary flexible capture set screw driver (lot 64008628) was returned.As returned, the flex shaft is cracked and deformed.The device shows wear & tear that indicates repeated use during a potential field age greater than 4 years.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.
Event or Problem Description
It was reported that the driver broke during set screw insertion.No further information is available.

• Brand Name: CEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER STANDARD 3.5 MM HEX
• Common Device Name: ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14874409
• Report Number: 0001822565-2022-01892
• Device Sequence Number: 5666152
• Product Code: HSB
• UDI-Device Identifier: 00889024063631
• UDI-Public: (01)00889024063631(10)64008628
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00249003507
• Device Lot Number: 64008628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown