MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 CURVED ACET SHELL INSERTER; 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	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial right hip surgery, the surgeon went to impact the acetabular cup into position and when the strike plate was struck, the end portion of the inserter broke.Surgical technique was utilized.There was no patient impact, and no medical or surgical intervention.There was no surgical delay and no surgical complications.Foreign body was not retained.No additional information available.
Additional Manufacturer Narrative
(b)(4).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
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 further event information is 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: b4;d4;g3;h2;h3;h4;h6 the following section was corrected: lot number: d4.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is 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: b4;g3;h2;h3;h6.The product was returned and evaluated.Visual examination of the returned product and provided pictures showed indentions to the strike plate and scuffing to the handle and junction location.The tip of the device had fractured and there were indentations near the fracture location.There were also indentations to the strike plate.The inside of the shaft of both the handle side and fractured piece had wear lines.The device has a potential field age of over 2 years, and it is unknown how many times the device was used during this period.Reported event was not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.A definitive root cause cannot be determined.Based on the product review, the complaint was 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.

• Brand Name: G7 CURVED ACET SHELL INSERTER
• 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: 19530607
• Report Number: 0001825034-2024-01588
• Device Sequence Number: 12656143
• Product Code: PBI
• UDI-Device Identifier: 00887868462511
• UDI-Public: (01)00887868462511(11)220207(10)785880
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup,Followup
• Report Date (Section B): 10/19/2024

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: 110003453
• Device Lot Number: 785880
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 06/13/2024; 09/30/2024; 10/16/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/24/2024; 10/14/2024; 10/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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 Age: 40 YR
• Patient Sex: Male