MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US METAGLENE HOLDER INTERNAL ROD; EXTREMITY INSTRUMENTS : HANDLES

Catalog Number	230787002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the mounting for the metaglene does not really work anymore, although they got completely new sieves about 6 months ago.It no longer grips the base plate and it constantly drops off, including the implant.There was no patient involvement.
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 recon described in this report.H11 additional narrative: added: d4 lot, d9.Corrected: d4 primary udi number.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: according to the information provided: "the mounting for the metaglene does not really work anymore, although they got completely new sieves about 6 months ago.It no longer grips the base plate and it constantly drops off, including the implant.No patient involvement".The packaging was returned to depuy synthes for evaluation.Visual inspection of the returned evidence revealed that only the plastic bag/packaging, labels and ifu were returned for evaluation.However, they do not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.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.A manufacturing record evaluation was performed for the finished device 5906463 lot number, and no non-conformances nor manufacturing irregularities were identified.The overall complaint was not confirmed as the evidence provided is not representative of the reported complaint.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: 1) quantity manufactured: (b)(4).2) date of manufacture: 10/07/2025.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu reference: w90966.Device history review: a manufacturing record evaluation was performed for the finished device (b)(4) lot number, and no non-conformances nor manufacturing irregularities were identified.H11 additional narrative: added: h4.Corrected: h3.

• Brand Name: METAGLENE HOLDER INTERNAL ROD
• Common Device Name: EXTREMITY INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23480597
• Report Number: 1818910-2025-19218
• Device Sequence Number: 10330079
• Product Code: HWA
• UDI-Device Identifier: 10603295116431
• UDI-Public: (01)10603295116431(10)5906463
• 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: 230787002
• Device Lot Number: 5906463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 01/12/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/09/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown