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

Catalog Number	110003454
Medical Device Problem Codes	Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the threaded inserter shaft would no assemble with the shell.There was not harm or health consequences to that patient.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-01225, 0001825034-2024-01226, 0001825034-2024-01227, 0001825034-2024-01228, 0001825034-2024-01230.Performed a visual inspection of the items returned.Confirmed that the lot numbers etched on the inserter threaded shafts match what is listed in the sub forms of the complaint.All 6 items returned show signs of use with damage to the hex feature area as well as some damage to the threads.There is also damage to the exterior portion of the collars as well.The complaint was unable to be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.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.

• 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: 19309265
• Report Number: 0001825034-2024-01229
• Device Sequence Number: 7009890
• Product Code: PBI
• UDI-Device Identifier: 00887868462528
• UDI-Public: (01)00887868462528(11)231027(10)091572
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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 Catalogue Number: 110003454
• Device Lot Number: 091572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown