MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ANGLED RMR DRIVER HUDSON; HIP INSTRUMENTS : ADAPTORS

Catalog Number	920010031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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.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: e1 initial reporter address line 1: (b)(6).
Event or Problem Description
It was reported that the instrument was fractured in the hudson connection area.No adverse patient consequences, no surgical delay.
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: d9.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 received, ¿the instrument fractured in the hudson connection area." the product was not returned to medtech orthopaedics; however, photos were provided for review.See attachment (b)(4).Photos wit lots¿.Photos were provided for review; however, the photos only show part and lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided contained insufficient evidence of the reported event.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 complaint condition.As part of 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: quantity of manufactured ¿ (b)(4) parts.Date of manufacturing ¿ 09.10.2019.Ant anomalies or deviations identified in dhr - none.Expiry date ¿ not applicable.Ifu reference - ifu-78410160 rev.F and lcn-920010031-disa rev.C.Device history review: a manufacturing record evaluation was performed for the finished device [lot/serial/batch] number, and no non-conformances / manufacturing irregularities were identified.
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: h4.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 instrument fractured in the hudson connection area.No adverse patient consequences, no surgical delay".The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the sub-assembly drive shaft was not returned for evaluation, therefore the reported event could not be verified.As for the returned sub-components (assembly frame, the cover drive shaft and the sub-assembly head drive), these were fully inspected and revealed signs of usage on its overall surface.No signs of breakage nor other damage was identified on the components surface.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 not confirmed as the observed condition of the angled rmr driver hudson would have not contributed 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 = > 1.Quantity of manufactured: (b)(4) parts.2.Date of manufacture: 09.10.2019 3.Any anomalies or deviations identified in dhr: none.4.Expiry date: not applicable.5.Ifu reference: ifu-78410160 rev.F and lcn-920010031-disa rev.C.Device history review = > a manufacturing record evaluation was performed for the finished device mj3642901 lot number, and no non-conformances nor manufacturing irregularities were identified.Corrected: h3.

• Brand Name: ANGLED RMR DRIVER HUDSON
• Common Device Name: HIP INSTRUMENTS : ADAPTORS
• 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: 23403246
• Report Number: 1818910-2025-18435
• Device Sequence Number: 10039150
• Product Code: HWE
• UDI-Device Identifier: 10603295221906
• UDI-Public: (01)10603295221906(10)MJ3642901
• 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,Followup,Followup
• Report Date (Section B): 11/12/2025

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: 920010031
• Device Lot Number: MJ3642901
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 12/04/2025; 01/05/2026; 01/05/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/13/2025; 12/18/2025; 01/07/2026; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• 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