MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HANDLE-T,HUDSON; HIP INSTRUMENTS : HANDLES

Catalog Number	530360
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the t handle won't hold corkscrew.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).
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 is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received.And states, that the event occurred in surgery with no delays.The t handle would not hold any instrument that was used.It also states, that the t handle was unable to be used on the corkscrew to remove the femoral head.There was no adverse reaction happened, due to instrument failure.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: it was reported, that the t handle won't hold corkscrew.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed, that there was no damage or defects with the s-rom*handle-t, hudson.A dimensional inspection was not performed, as it is not applicable to the complaint condition.A functional test was performed.Mating device (b)(4) (quickset 1pc flex drill bit 35) was coupled to the s-rom*handle-t, hudson without problems.The device works as intended.The complaint condition was not able to be replicated.The overall complaint was not confirmed, as the s-rom*handle-t, hudson was found to have no damage or defects.No definitive root cause could be determined.There was no indication, that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined, that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.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.

• Common Device Name: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18409714
• Report Number: 1818910-2023-26118
• Device Sequence Number: 8711006
• Product Code: LXH
• UDI-Device Identifier: 10603295171546
• UDI-Public: 10603295171546
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/28/2023

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: 530360
• Device Lot Number: ABC44749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 12/28/2023; 01/16/2024; 01/23/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/02/2024; 01/17/2024; 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2014
• 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: Male