MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL SET SCREW HEX DRIVER TORQUE LIMITING SIZE 2.0 MM; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during that kit inspection at a distributor warehouse, a fractured instrument was found.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Foreign source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs.Visual examination of the provided pictures identified signs of use and that the instrument was broken into two pieces.Device history record was reviewed and no discrepancies were found.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified signs of repeated use and that the device is fractured.Root cause was unable to be determined.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL SET SCREW HEX DRIVER TORQUE LIMITING SIZE 2.0 MM
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13046280
• Report Number: 0001822565-2021-03616
• Device Sequence Number: 1728779
• Product Code: HXX
• UDI-Device Identifier: 00889024219595
• UDI-Public: (01)00889024219595(10)65091756
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2023

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: 00598707100
• Device Lot Number: 65091756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 02/15/2022; 08/09/2023
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/15/2022; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown