MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEIN PIN 3/32DX9LG ST5; Pin, Fixation, Smooth

Catalog Number	47018700259
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): d10: item # 47430904601, drill 2.5mm sterile, lot # 67353842.Item # 47430706100, tm glen 6mm drl cann ster, lot # 66808957.Item # 00436201500, 26 mmtm rvs base plt 15m, lot # 67363523.Item # 0104223030, invers/revers scr syst 4.5-30, lot # 3178819.Item # 0104223030, invers/revers scr syst 4.5-30, lot # 3220079.Item # 00436003600, tm reverse glenosphere 3, lot # 67442741.Item # 00434901213, tm reverse stem 12mm x 130mm, lot # 67605753.Item # 00434903909, spacer 9mm, lot # 66188037.Item # 00434903600, 36mm poly liner plus 0mm ofs, lot # 67616342.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.
Event or Problem Description
It was reported that a glenoid guide pin broke.Attempts have been made and no further information has been provided.

• Brand Name: STEIN PIN 3/32DX9LG ST5
• Common Device Name: Pin, Fixation, Smooth
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24902962
• Report Number: 0001822565-2026-01313
• Device Sequence Number: 10011825
• Product Code: HTY
• UDI-Device Identifier: 00889024084377
• UDI-Public: (01)00889024084377(17)350204(10)67135350
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 47018700259
• Device Lot Number: 67135350
• Was Device Available for Evaluation?: No
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/19/2026; 09/29/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/14/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown