MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR METAL IMPACTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that during surgery for right shoulder arthroplasty that the glenoid impactor broke.There was no harm or injury to patient and no reported delay.The procedure was completed using another impactor.Due diligence is complete.No additional information is available.
Event or Problem Description
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d4, g1, g3, g6, h2, h3, h4, h6, h11.Visual examination of the returned product identified the grey tip is fractured.Wear & tear is seen that indicates repeated use during a potential field age greater than 4 years.Fracture surface artifacts of hackle marks, river lines, and a probable bending hinge are visible.An uncommon feature of whitened, possibly from smearing, artifacts is present, which may suggest contact damage accumulated during impacting (prior to complete fracture) or after fracture (e.G.Continued use after fracture).These fracture surface artifacts suggest the bending overload failure mode, possibly initiating in fatigue review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed as product was returned.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.

• Brand Name: COMPR METAL IMPACTOR
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 20384353
• Report Number: 0001825034-2024-02347
• Device Sequence Number: 12380312
• Product Code: PHX
• UDI-Device Identifier: 00880304731516
• UDI-Public: (01)00880304731516(11)180831(10)214350
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• 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
• Report Date (Section B): 01/10/2025

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: 110029132
• Device Lot Number: 214350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2018
• 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: 72 YR
• Patient Sex: Male