MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STRAIGHT MOD SCRDRVR 3.5MM; INSTRUMENT, HIP

Catalog Number	010002749
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the straight driver fractured.There was no patient injury reported as a result of the malfunction.There is no further information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 d4: lot d9 g3 g6 h2 h11.
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.The following sections were updated: b4;d4;g3;h2;h3;h4;h6 product was returned and evaluated.Visual examination of the returned product identified fractured at the hex tip.No fractured hex segment was returned with device for evaluation.Device showed signs of use with nicks and scratches around the tapered surface at the hex end.There were nicks and scratches present along the main body/shaft and near the square connection end.No other damage was noted during visual evaluation review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information provided; therefore, unable to perform a compatibility check.Medical records were not provided.A definitive root cause cannot be determined.This complaint was confirmed based on the returned, fractured device.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 is available at the time of this report.

• Brand Name: G7 STRAIGHT MOD SCRDRVR 3.5MM
• 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: 21834099
• Report Number: 0001825034-2025-01088
• Device Sequence Number: 11805955
• Product Code: PBI
• UDI-Device Identifier: 00887868461941
• UDI-Public: (01)00887868461941(11)220907(10)ZB7211961
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2025

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: 010002749
• Device Lot Number: ZB7211961
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 06/25/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 05/20/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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: Unknown