MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SCREW GUIDE PIN D1.2X5; EXTREMITY INSTRUMENTS : PIN GUIDES

Catalog Number	230790004
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2025
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 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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 on (b)(6) 2025 during a rsa surgery performed on shoulder for cta, a part of screw guide pin broke and remained inside the body (in the bone).Details were as follows.After the metaglenn was placed, a drill and a drill guide were used to create the pre-hole.The screw guide pin in question was placed in the bone hole and a locking screw was inserted.The surgeon then attempted to remove the screw guide pin in question but could not do so manually.The screw guide pin in question could not be removed even with a pin remover, it was finally removed by grasping it with the jacobs chuck of the handpiece and rotating it.However, a postoperative x-ray showed that a broken screw guide pin remained at the tip of the screw.The surgeon used the image to check at different angles, confirmed that the screw guide pin was likely inside the bone.The surgery was completed successfully without any surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

• Brand Name: SCREW GUIDE PIN D1.2X5
• Common Device Name: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21243654
• Report Number: 1818910-2025-01552
• Device Sequence Number: 19727943
• Product Code: LXH
• UDI-Device Identifier: 10603295116530
• UDI-Public: (01)10603295116530
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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: 230790004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female