MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION POLY IMPACTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110028055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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.If any further information is found that 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
It was reported the impactor fractured when impacting the glenosphere while following the correct surgical procedure.The process of impacting the glenosphere was completed to the surgeon's satisfaction with the instrument.However, it was broken in the process.No broken pieces fell into the patient.And the patient has not experienced any harm due to the event.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a3; b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.The reported is confirmed through evaluation of the returned device.Visual examination of the returned products identified the device shows signs of use as well as wear and tear.The base plate has scratches and dents from striking.The handle and shaft of the device has scratches and knicks from use as well.The complaint states that the tip fractured but the device was returned without the tip.Measured features of the handle to confirm the impactor is conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.It was reported that the 3-1 impactor fractured during impaction of the glenosphere.Per the surgical technique, under section humeral tray and bearing assembly "with two firm strikes of the humeral tray/ bearing impactor (405825 or 110028055), impact the humeral bearing into the humeral tray".As noted in the surgical technique, the listed part numbers are intended to be used for the glenosphere impaction 407280 or 110029132.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 further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE INSTRUMENTATION POLY 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: 23599166
• Report Number: 0001825034-2025-03710
• Device Sequence Number: 9337008
• Product Code: PHX
• UDI-Device Identifier: 00887868469978
• UDI-Public: (01)00887868469978(11)220404(10)791360
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 04/29/2026

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: 110028055
• Device Lot Number: 791360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male