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

Catalog Number	920010031
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
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 an optimis reamer handle was unable to lock; surgical team was unable to properly assemble the handle during op setup.They were unable to assemble it correctly due to the pin getting stuck.It seems to have bent out of shape or is jamming and is not in usable condition without repairs.This was noticed immediately after opening the loan tray before the case.There was no patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: optimis reamer handle unable to lock, seems to have bent out of shape or is jamming and is not in usable condition without repairs.See attached photos for reference of jammed parts.The product was returned to j&j medtech orthopaedics for evaluation, additionally photos were provided for review.The photo investigation revealed nothing indicative of a device nonconformance.However, during the visual inspection of the returned device it was found that the frame and the cover driveshaft were disassemble and exhibits spots of what appears to be corrosion and signs of heavy usage; therefore, jammed condition cannot be confirmed.Additionally, no signs of bending were observed.Corrosion is not an expected failure if it is used as intended and the parameters within the instructions for use (ifu) are followed for cleaning, decontamination and sterilization.The device had experienced around 15 years of usage and the number of procedures (cycles) it had gone through its life in the field is unknown.Although the observed condition of the instrument cannot be attributed to design or manufacturing, with the information available, a definitive root cause cannot be established at this time due to there being multiple factors that may influence.Additionally, the sub-assembly driveshaft and the sub-assembly head were not returned for evaluation.This condition may occur during the cleaning/sterilization process, particularly when the components are assembled or disassembled.As these procedures are often repeated, there is an increased risk of components going missing.However, without concrete evidence or further information, it is not possible to determine a root cause.A functional was performed with the frame and the driveshaft and they were not able to assemble as intended due to the heavy wear condition of the device, the reported ¿will not lock/unlock ¿condition was able to be replicated.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 angled rmr driver hudson would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h3.
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 which 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 is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
The device malfunction, functional: will not lock/unlock, will no longer be reported as there has not been a serious injury associated with this failure within the past 2 years.Please consider this the last manufacturer report number submitted against this malfunction.

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20677727
• Report Number: 1818910-2024-23717
• Device Sequence Number: 20957276
• Product Code: HWE
• UDI-Device Identifier: 10603295221906
• UDI-Public: (01)10603295221906(10)P00809001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup,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: 920010031
• Device Lot Number: P00809001
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 01/23/2025; 08/20/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/13/2025; 01/24/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2005
• 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