MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR BROACH SIZE 6; INSTRUMENT, HIP

Catalog Number	574999060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.The product is in process of being returned to zimmer biomet for investigation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial total hip arthroplasty, the broach instrument fractured at the handle while preparing the socket bed.There was a twenty (20) minute surgical delay to retrieve the fractured instrument and a back up device.The surgery was completed without further complication.There was no patient impact and no adverse events have been reported as a result of the malfunction.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04): rasp.Visual examination of the returned product, identified the reported event of rasp fracture at the handle is confirmed.The handle has fractured off and left a pit on the rasp.All fragments (2) are accounted for.Apart from the fracture.The device shows signs of wear in the form of scratches and nicks.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed, by a health care professional.Review of the available records, identified the following: during the initial surgery, while rasping, the rasp broke off at the connection to the rasp handle.The device was able to be removed with some effort.No other complications noted.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.If any further information is found, which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: AVENIR BROACH SIZE 6
• Common Device Name: INSTRUMENT, HIP
• 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: 18940554
• Report Number: 0001822565-2024-00981
• Device Sequence Number: 8381665
• Product Code: LZO
• UDI-Device Identifier: 00889024510166
• UDI-Public: (01)00889024510166(10)65000598
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182048
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 574999060
• Device Lot Number: 65000598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Male