MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HUMERAL STEM PIN PUNCH; SHOULDER INSTRUMENT - PIN PUNCH

Catalog Number	620101121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional manufacturer narrative: a1, a2, a3, a4: device used in a veterinary case: no patient information will be reported.
Event or Problem Description
It was reported by spd that the instrument broke during washing.The issue did not happen in surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported by spd that the instrument broke during washing.The issue did not happen in surgery.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the weld between the body of the device and the standard fixation pin was broken, resulting in the pin detaching from the humeral stem pin punch.The broken fragment was not returned for evaluation.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the humeral stem pin punch would have contributed to the complained device issue.Based on the investigation findings, the root cause is traced to design.The product issue has been addressed through j&j medtech orthopaedics quality system.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H11 additional narrative: added: d9 corrected: h3.

• Brand Name: HUMERAL STEM PIN PUNCH
• Common Device Name: SHOULDER INSTRUMENT - PIN PUNCH
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21992467
• Report Number: 1818910-2025-07473
• Device Sequence Number: 11884052
• Product Code: MBF
• UDI-Device Identifier: 10603295539315
• UDI-Public: (01)10603295539315(10)175365
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K202716
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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: 620101121
• Device Lot Number: 175365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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