MAUDE Adverse Event Report: ZIMMER BIOMET, INC. T-15 DRIVER; TRAUMA, INSTRUMENT

Model Number	110017562
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign: (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 report will be submitted.
Event or Problem Description
It was reported that the product was found to be broken in the warehouse.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: (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 report will be submitted.
Event or Problem Description
It was reported that the product was found to be broken in the warehouse.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided photograph identified that the tip of the device is fractured.The fractured off piece is also pictured.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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
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.The following sections were updated: b4, b5, d2, g1-2, g3, g7, h1, h2, h6, h10 upon receipt of additional information it has been determined that the reported device was not fractured but found to be worn.As there is no previously reported serious injury with this event, this complaint will be considered not reportable.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 worn.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: T-15 DRIVER
• Common Device Name: TRAUMA, INSTRUMENT
• 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: 13426622
• Report Number: 0001825034-2022-00261
• Device Sequence Number: 11750476
• Product Code: HRS
• UDI-Device Identifier: 00887868135064
• UDI-Public: (01)00887868135064(10)112515
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K143697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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: 110017562
• Device Catalogue Number: 110017562
• Device Lot Number: 112515
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 06/19/2023
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 04/21/2022; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose