MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.5 MM HEX CANNULATED SCREWDRIVER STANDARD QUICK-CONNECT; TRAUMA, INSTRUMENT

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the tip is twisted.Additionally, it was found that the tip is fractured.Both fractured pieces were returned.Root cause was unable to 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 instrument was fractured during the inspection.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: 2.5 MM HEX CANNULATED SCREWDRIVER STANDARD QUICK-CONNECT
• Common Device Name: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9555329
• Report Number: 0001822565-2019-05457
• Device Sequence Number: 3096234
• Product Code: HWE
• UDI-Device Identifier: 00889024061064
• UDI-Public: (01)00889024061064
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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 Model Number: N/A
• Device Catalogue Number: 00236016625
• Device Lot Number: 64317492
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1