MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STRAIGHT EXACT BROACH HANDLE; INSTRUMENT, HIP

Catalog Number	31-555500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: poland.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
It was reported the instrument was found to be fractured.There was no patient involvement.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; d4; g3; h2; h3; h4; h6 corrected: b5; d9; h6 b5: it was noted during diligence that there was no harm to the patient, not that no patient was involved.D9: product was never recceived from the hospital, though it was expected to return.H6: code updated to reflect no harm to the patient, verses no patient involvement.Visual examination of the provided pictures identified the strike plate broke off the device at the weld and the spring disassembled.The device shows signs of use.No further evaluation can be made from the provided picture.This complaint is confirmed based on the provided picture.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause cannot be established.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 fractured during a procedure.There was no harm or impact to the patient.Attempts have been made and no further information is available.

• Brand Name: STRAIGHT EXACT BROACH HANDLE
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16673780
• Report Number: 0001825034-2023-00732
• Device Sequence Number: 6379526
• Product Code: HXC
• UDI-Device Identifier: 00880304006973
• UDI-Public: (01)00880304006973(11)180623(10)ZB18030
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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 Catalogue Number: 31-555500
• Device Lot Number: ZB180303
• Was Device Available for Evaluation?: No
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2018
• 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: Unknown