MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 METAGLENE HOLDER; EXTREMITY INSTRUMENTS : HANDLES

Catalog Number	230787005
Medical Device Problem Codes	Device-Device Incompatibility (2919); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively there were difficulties attaching the metaglene template with the instrument´s blue handle.It kept coming loose.There was no surgical delay, and no adverse patient consequences were reported.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary = > intraoperatively there were difficulties attaching the metaglene template with the instrument´s blue handle, it kept coming loose.No surgical delay, no adverse patient consequences reported.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the tip was severely deformed.A functional evaluation was performed and it revealed the metaglene holder was able to assemble to the returned metaglene holder internal rod.Due to the observed deformity ath the tip, the metaglene holder was not able to assemble to the returned metaglene positioner plate.No looseness was found.The complaint condition was replicated.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.¿ a dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the metaglene holder would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause is traced to unintended use, and 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 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 = > 1) quantity manufactured: 20 2) date of manufacture: 10/05/2021 3) any anomalies or deviations identified in dhr: none 4) expiry date: n/a 5) ifu-w90966 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: corrected: h3, h4.

• Brand Name: METAGLENE HOLDER
• Common Device Name: EXTREMITY INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21423200
• Report Number: 1818910-2025-02836
• Device Sequence Number: 8189545
• Product Code: HWA
• UDI-Device Identifier: 10603295116462
• UDI-Public: (01)10603295116462(10)5381060
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,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: 230787005
• Device Lot Number: 5381060
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 04/11/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/17/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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