MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION 2-PRONG GLENOSPHERE INSERTER/IMPACTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110028879
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the glenosphere impactor tip broke during impaction to the glenosphere.The correct surgical technique was used.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.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.
Additional Manufacturer Narrative
(b)(4).H8.This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h8.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
It was reported that the glenosphere impactor tip broke during impaction to the glenosphere.The correct surgical technique was used.The surgery was completed using the secondary impactor.The pieces did go into the patient but were all retrieved and then thrown away.This item had been used in surgery before.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.Attempts have been made, and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.The reported cannot be confirmed.Visual examination of the provided pictures identified the pad for the impactor is cracked.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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: COMPREHENSIVE INSTRUMENTATION 2-PRONG GLENOSPHERE INSERTER/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: 24069079
• Report Number: 0001825034-2026-00137
• Device Sequence Number: 10282395
• Product Code: PHX
• UDI-Device Identifier: 00880304731394
• UDI-Public: (01)00880304731394(11)180801(10)802050
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 04/24/2026

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: 110028879
• Device Lot Number: 802050
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 03/11/2026; 04/22/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/09/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female