MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STRAIGHT SHELL INSERTER; 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	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: brazil.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 when using the straight shell insertion instrument, the screw that fixes the instrument to the metal acetabulum was broken.When trying to attach the metal acetabulum to the cable it did not hold, however, the surgeon was able to fix the acetabulum even with the broken instrument.No known impact or consequence to the patient reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, g3, g6, h2, h3, h4, h6.Visual examination of the provided pictures identified the shell inserter instrument with a fractured screw tip.No image of fractured off pieces were provided.No other observations could be made based on the provided image alone.No product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.A definitive root cause cannot be determined.However, based on the reported information, a zimmer biomet instrument was noted to be damaged/worn and was used to complete the procedure.Please note, as per the instructions for use, instrument/provisional use, care and sterilization, it states under warnings "do not use instruments/provisionals that are deformed, corroded, damaged or worn.They may not perform as intended." based on the provided image of the fractured instrument, the complaint is confirmed.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 for trends.
Event or Problem Description
No additional information to report at this time.

• Brand Name: STRAIGHT SHELL INSERTER
• Common Device Name: HIPS, INSTRUMENTS
• 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: 21333429
• Report Number: 0001822565-2025-00298
• Device Sequence Number: 18121417
• Product Code: LXH
• UDI-Device Identifier: 00889024133945
• UDI-Public: (01)00889024133945(10)65187919
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 00780401520
• Device Lot Number: 65187919
• Was Device Available for Evaluation?: No
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: Male