MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET FLEX CLAMPING BROACH HNDL; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while broaching femur the circular strike plate on the end of the broach handle broke off.It appears the weld failed after being used many times.Nothing fell into the patient and the procedure was completed using a second device.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were not provided.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
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
There is no update to the prior event description provided.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.One offset flex clamp broach hndl item# 31-555408 lot# 609030 was returned and evaluated.Upon visual inspection the strike plate has fractured from the handle of the device.The handle has impact marks along the shaft of the device.The strike plate has indentations on both the top and bottom side of the plate.The features of the fracture surface visually align in which an overload fracture failure mode was identified.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Event is confirmed via returned product.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.

• Brand Name: OFFSET FLEX CLAMPING BROACH HNDL
• 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): .; 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: 19522072
• Report Number: 0001825034-2024-01561
• Device Sequence Number: 8540407
• Product Code: LXH
• UDI-Device Identifier: 00880304522749
• UDI-Public: (01)00880304522749(11)170116(10)609030
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup,Followup
• Report Date (Section B): 11/15/2024

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 Model Number: N/A
• Device Catalogue Number: 31-555408
• Device Lot Number: 609030
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 10/21/2024; 11/14/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/23/2024; 10/31/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2017
• 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: Prefer Not To Disclose