MAUDE Adverse Event Report: Zimmer Biomet, Inc. COMPR RVS GLENO 2-PRNG INS/IMP; Orthopaedic implant inserter/extractor, reusable

Catalog Number	110028879
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the glenosphere inserter pad broke.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: item # 405883, comp rvs 3.2mm drl, lot # 67906323.Item # 405800, comp.Rev shldr 9 in steinmann, lot # 67839655.Item # 405889, comp rvs 2.7mm dia drl, lot # 67839759.Item # 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 67704482.Item # 115310, comp rvrs shldr glnsp std 36mm, lot # j8135730.Item # 115396, comp rvs cntrl 6.5x30mm st/rst, lot # 67652355.Item # 180552, comp lk scr 3.5hex 4.75x25 st, lot # 67770073.Item # 180551, comp lk scr 3.5hex 4.75x20 st, lot # 67905560.Item # 180553, comp lk scr 3.5hex 4.75x30 st, lot # 67867676.Item # 115313, comp rvsr shldr glnsp +3 36mm, lot # j8106834.Item # 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 67603280.Item # 110031425, hmrl bearing 36 mm +3 vite, lot # 67697260.Item # 113610, comp primary stem 10mm micro, lot # 67823976.Item # 110031399, hmrl tray std std, lot # 67934219.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: COMPR RVS GLENO 2-PRNG INS/IMP
• Common Device Name: Orthopaedic implant inserter/extractor, reusable
• 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 ; +1(574)526-0384
• MDR Report Key: 50476951
• Report Number: 0001825034-2026-02598
• Device Sequence Number: 18670200
• Product Code: KWS
• UDI-Device Identifier: 00880304731394
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 885930
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 narrative
• Patient Sex: Unknown