MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ANT BROACH HANDLE - L; HIP INSTRUMENTS : HANDLES

Catalog Number	259807350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
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.
Event or Problem Description
It was reported that a part inside instrument is broken.Was surgery time extended as a direct result of incident? no what action was taken/required to manage the problem during the procedure? with same as product.
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.
Event or Problem Description
Additional information received: a.Was/were there any adverse consequence/s that affected the patient because of the reported event? -there was no adverse consequences for the patient because of the reported event.B.If depuy synthes instrumentation broke during surgery, were all pieces retrieved from the patient? -we have no information that the piece is still in the patient.C.Was surgery time extended due to a depuy synthes product? if yes, how long? -no surgical time extended due to the event.D.Did the instrument break into two or more pieces? -two pieces.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: broken part inside instrument.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device confirmed a breakage condition on the hinge.There were observed impaction nick marks on areas which are not intended to be impacted specially on the lever and handle.Fragment was not returned for evaluation.The nicks observed on the device can be attributed to a combination of heavy use and unintended impaction forces, most likely from bottom-up impactions applied to disengage the device.These repeated unintended forces could have introduced stress to the device structure, potentially leading to the hinge breakage.A functional test was performed with a laboratory sample mating device, and the ant broach handle - l was successfully assembled without any issues.There were no signs of looseness or difficulties observed during assembly.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 ant broach handle - l would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, 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: 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.

• Brand Name: ANT BROACH HANDLE - L
• 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 46581-0988 ; 3035526892
• MDR Report Key: 20125129
• Report Number: 1818910-2024-18494
• Device Sequence Number: 18013130
• Product Code: HTQ
• UDI-Device Identifier: 10603295148296
• UDI-Public: (01)10603295148296(10)AB5203057
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2024

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: 259807350
• Device Lot Number: AB5203057
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 11/19/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/18/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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