MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US METAGLENE GUIDE PIN DIA 2.5MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Catalog Number	230787004
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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.
Event or Problem Description
It was reported that during surgery when doing an anatomic global icon, when using the drill on the metaglene guide pin dia 2.5 mm, the pin got damaged as seen on pictures.It was even a bit of metal on the drill shaft after extracting it from the glenoid.The metal was very thin, like the drill had shaved of a bit of the guide pin as seen on pictures.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received that "last week on thursday (b)(6) during surgery when doing a anatomic global icon, when using the drill on the metaglene guide pin dia 2.5 mm [product code removed], the pin got damaged as seen on pictures.It was even a bit of metal on the drill shaft after extracting it from the glenoid.The metal was very thin, like the drill had shaved of a bit of the guid pine as seen on pictures.The item has been thrown in trash." the product was not returned to depuy synthes; however, photos were provided for review.The photo investigation revealed that 230787004, metaglene guide pin dia 2.5mm had scratches and nicks along the device's body.This type of damage is consistent with other tools and hard edges coming in contact with the device, properly handling and attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the metaglene guide pin dia 2.5mm would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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: a manufacturing record evaluation (nc search) was performed for the finished device product code (230787004) lot number (5620321), and no non-conformances / manufacturing irregularities were identified.

• Brand Name: METAGLENE GUIDE PIN DIA 2.5MM
• Common Device Name: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23770791
• Report Number: 1818910-2025-21600
• Device Sequence Number: 10615945
• Product Code: LXH
• UDI-Device Identifier: 10603295116455
• UDI-Public: (01)10603295116455(10)5620321
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 230787004
• Device Lot Number: 5620321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown