MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BALL NOSE GUIDE WIRE 100CM; TRAUMA INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: france.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
Event or Problem Description
It was reported approximately 3 weeks ago during an initial surgery there was a breakage of the file guide used in the context of the arthroplasty of the right hip, leaving in the diaphyseal shaft a part of the stem.The next day there was a revision for the removal of the broken piece, which could not be removed.
Additional Manufacturer Narrative
(b)(4).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 further reported that the patient had an initial right total hip arthroplasty approximately 2 months ago.Subsequently, during the procedure the femoral shaft was found to be very dense, and it was decided to perform motorized reaming.During the reaming, the guide pin fractured leaving part of the pin in the femoral shaft.The surgery could not be completed due to a lack of necessary equipment as the surgeon now needed to complete a femorotomy and implant a long revision stem.The patient was transferred to another hospital where the surgery was completed a day later.
Additional Manufacturer Narrative
(b)(4) reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: BALL NOSE GUIDE WIRE 100CM
• Common Device Name: TRAUMA INSTRUMENT
• 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: 16499635
• Report Number: 0001825034-2023-00353
• Device Sequence Number: 20407335
• Product Code: FZX
• UDI-Device Identifier: 00887868027864
• UDI-Public: (01)00887868027864(17)310908(10)415690
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 281001100
• Device Lot Number: 415690
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 07/26/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/22/2023; 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Unknown
• Patient Weight: 120 KG