MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION POLY IMPACTOR; INSTRUMENT-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	02/11/2025
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 that during an initial procedure, the impactor tip fractured during impaction while following the correct surgical technique.The procedure was completed with alternate instrumentation.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.The case was completed without any adverse outcomes to the patient.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10 the reported event was confirmed through product return.Visual examination of the returned product identified signs of repeated use and wear.The threads of the impactor have epoxy residue.The wrong impactor tip was returned with the impactor.The print calls for a black poly impactor tip and the tip returned was grey.The tip of the impactor is fractured and not all of the pieces were returned.The features of the fracture surface visually confirm that an overload fracture failure mode was identified.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.The product returned with the incorrect impactor pad, indicating it has been switched in the field.Per design the impactor pad is epoxied on at the time of manufacture.However, it is unknown if removal of the tip caused or contributed to the reported event.Therefore, a definitive root cause cannot be determined.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
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE INSTRUMENTATION POLY IMPACTOR
• Common Device Name: INSTRUMENT-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: 21536730
• Report Number: 0001825034-2025-00573
• Device Sequence Number: 7099157
• Product Code: PHX
• UDI-Device Identifier: 00880304731301
• UDI-Public: (01)00880304731301(11)190617(10)467280
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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 Catalogue Number: 110028055
• Device Lot Number: 467280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female