MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER STRAIGHT SHELL INSERTER; HIP, INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that while implanting the acetabular cup, the threads of the instrument broke off inside of the cup.The cup had good fixation, so the surgeon decided to leave the cup as it was, with no consequences to the patient.The patient¿s anatomy did not contribute to the event.It was reported that the surgical technique was used.There was no reported patient impact, no patient injury, no medical/surgical interventions, no surgical delays, no foreign body retained, and no surgical complications.No additional information available.
Event or Problem Description
No further event information is available at the time of this report.
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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified strike plate shows indentations from previous uses.Nicks, gouges, and scratches were noted to the device.Threaded tip is confirmed fractured.Fractured piece(s) were not returned with the device for review.During evaluation it was noted the hex bolt is jammed and would not rotate or move in or out as intended.No other damage was noted.The inserter was submitted for further analysis.Analysis determined a bending overload mode of failure.Review of the device history records identified no deviations or anomalies during manufacturing.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
Additional information received.It was reported that the tip of the hex bolt was retained in the acetabular shell dome hole portion of the prosthesis.The acetabular shell had proper fixation with no foreseeable loosening.The surgeon proceeded utilizing the corresponding surgical technique for total hip arthroscopy.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;b5;d4;g3;h2;h3;h4;h6.The following section was corrected: d1.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
It was reported that while implanting the cup, the threads on the tip of the inserter broke off in the cup.The tip of the hex bolt was retained in cup and the foreign body was retained by the patient.The shell had proper fixation, so the surgeon left the cup implanted and continued the procedure.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

• Brand Name: ZIMMER STRAIGHT SHELL INSERTER
• Common Device Name: HIP, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18326184
• Report Number: 0001822565-2023-03518
• Device Sequence Number: 7250703
• Product Code: LXH
• UDI-Device Identifier: 00887868550737
• UDI-Public: (01)00887868550737(11)141222(10)62935747
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00780401520
• Device Lot Number: 62935747
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 04/03/2024; 04/03/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/02/2024; 04/16/2024; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female