MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 CURVED INSERTER THD SHAFT; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Codes	Separation Failure (2547); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip surgery after cup trial use, the inserter threaded shaft got stuck in the curved inserter.The inserter threaded shaft was deformed after cup trial use and could not be attached to implant.Therefore, the cup trial could not be removed from the curved inserter.The surgeon tried to remove it with a screwdriver, but it was too hard to remove.Surgery was completed using a straight inserter.It was reported that there were no issues found with the cup trial or curved inserter.The issue was with the inserter threaded shaft, which was removed after the surgery, and found to be deformed.There was no adverse impact to the patient and no medical interventions.There was a 05-minute delay for instrument replacement.There were no contributing conditions related to the event.Surgical technique for the product was utilized.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# unknown lot# unknown / unknown g7 curved acet shell inserter cat# unknown lot# unknown / unknown cup trial g2: foreign: country: japan 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.Visual examination of the returned threaded shaft/provided pictures identified damage to the lip of the hex feature along with scuffing to the inside of the hex.There was damage visible to the threads and scuffing to the flat of the threaded area.The length, head diameter, and shaft diameter were checked and found to meet product specifications.Review of the device history records for the threaded shaft identified no deviations or anomalies during manufacturing.Insufficient information was provided; therefore, the compatibility check could not be performed as the part and lot identification were not provided for the shell inserter.Medical records were not provided.A definitive root cause cannot be determined.Based on the product review, the complaint is confirmed.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 CURVED INSERTER THD SHAFT
• 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: 20672684
• Report Number: 0001825034-2024-02673
• Device Sequence Number: 15578939
• Product Code: PBI
• UDI-Device Identifier: 00887868462528
• UDI-Public: (01)00887868462528(11)240327(10)094447
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 110003454
• Device Lot Number: 094447
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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