MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS 2.7MM DIA DRL; EXTREMITIES, INSTRUMENT

Model Number	405889
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the inspection of the loner kit, the product was found to be broken.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).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.Product not returned.
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.Visual examination of the provided picture of the drill identified the lot number is verified.Fracture cannot be confirmed.Visual examination of the provided picture of the impactor confirms the strike plate has fractured off and the impactor shows signs of wear; discoloration and scratch marks throughout.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.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.Proposed annex g code- mechanical (g04) - drill.Visual examination of the returned product identified the drill has gouges on the flutes of the drill bit and the tip of the drill bit is fractured and was not all returned.The impactor has nicks, gouges and scratches around the entire surface.The strike plate has fractured away from the impactor body.All pieces are returned.It remains that 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
No further event information available at the time of this report.

• Brand Name: COMP RVS 2.7MM DIA DRL
• Common Device Name: EXTREMITIES, 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: 13288504
• Report Number: 0001825034-2022-00118
• Device Sequence Number: 4728110
• Product Code: HTW
• UDI-Device Identifier: 00880304469877
• UDI-Public: (01)00880304469877(17)281214(10)830350
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2023

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: 405889
• Device Catalogue Number: 405889
• Device Lot Number: 830350
• 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: 12/24/2021
• Supplement Date Received by Manufacturer: 03/23/2022; 07/19/2023
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/30/2022; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose