MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR RVS GLENO 2-PRNG INS/IMP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number	110028879
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the surgeon was using the instrument the tip fractured.There was no report of a foreign body retained or harm to the patient.Attempt has been made to obtain additional information.No additional information has been received.
Additional Manufacturer Narrative
(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Attempts have been made to gather all product identification information, and no further information has been provided.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6 visual examination of the provided pictures identified a piece of the impactor pad has broken off.Part and lot information is not visible.Lot identification is necessary for review of device history records; lot identification was not provided.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was reported that the surgical tech noticed after the surgeon removed the instrument that the tip had cracked.There were no pieces missing at the time, however after the cleaning cycle there was a piece of the tip missing.There was no foreign body retained or harm to the patient.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4; d9; g2; g3; g6; h1; h2; h3; h4; h6.Visual examination of the returned product/provided pictures identified the inserter/impactor returned shows signs of use with impaction marks/gouges on the strike plate, wear and tear on the handle and both prongs on the distal end of the inserter are damaged.The black poly impactor tip is fractured and not all pieces were returned with the device.Dimensional analysis where measured was conforming.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPR RVS GLENO 2-PRNG INS/IMP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• 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: 21929939
• Report Number: 0001825034-2025-01245
• Device Sequence Number: 18399940
• Product Code: PHX
• UDI-Device Identifier: 00887868470011
• UDI-Public: (01)00887868470011(11)220509(10)865070
• 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,Followup
• Report Date (Section B): 09/10/2025

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 Catalogue Number: 110028879
• Device Lot Number: 865070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 08/12/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/03/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown