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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the curved inserter threaded shaft screw broke while trying to disengage the inserter handle from the acetabular cup implant while it was in the patient.The surgeon removed the cup from the patient and implanted a new cup.The screwdriver was returned fractured and no additional information has been provided regarding the event/fracture.
Additional Manufacturer Narrative
(b)(4).D10: 110010248 g7 osseoti 4 hole shell 60mm g (b)(6).110003454 g7 curved inserter thd shaft unknown.110003453 g7 curved acet shell inserter (b)(6).Visual examination of the returned product identified wear from previous uses in the hex for the threaded shaft.Device is fractured.Distal threaded tip remains in the shell.Proximal side with hex was returned loose.Shell outer spherical diameter, rim, and inner spherical surface have damage from attempted use and to be separated from instruments.No other damage was noted.Nicks and scratches are noted from previous uses for the screwdriver.Hex tip is confirmed to have fractured off and remains in the inserter threaded shaft in the shell.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined for the threaded shaft, cup, and screwdriver.This complaint was confirmed based on the returned devices.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 trends.

• Brand Name: G7 STRAIGHT MOD SCRDRVR 3.5MM
• Common Device Name: HIPS, INSTRUMENTS
• 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: 22620804
• Report Number: 0001825034-2025-02238
• Device Sequence Number: 15972176
• Product Code: PBI
• UDI-Device Identifier: 00880304926912
• UDI-Public: (01)00880304926912(11)180730(10)ZB180501
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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 Model Number: N/A
• Device Catalogue Number: 010002749
• Device Lot Number: ZB180501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• 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: 07/09/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2018
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Male