MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 BROACH CORAIL AMT 13; HIP INSTRUMENTS : BROACHES

Catalog Number L20413

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).H6:part/ component/ sub assembly term not applicable (g07001).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photographs revealed that the broach has signs of debris near the cutting teeth.However, based on the available evidence and quality of the photograph provided it is not possible to confirm that the broach is having corrosion or rust.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 Description

It was reported that device has rust stains.

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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - rust.It was reported that during the surgery, rust stains were found in these three devices (as the attached photo shows).There were no adverse consequences to the patient.No additional information could be provided the device associated with this report was returned to depuy synthes for evaluation.Visual inspections of the returned sample revealed that broach corail amt 13 shows signs of corrosion on the broach.Where corrosion/oxidation is identified around the cutting surface of the device, alongside damage consistent with normal wear, this suggests that the passive layer of the metal has been worn down from repeated use (due to normal use damage) allowing for the metallic surface underneath to become susceptible to corrosion/oxidation.Therefore, the potential cause of the observed corrosion/oxidation is consistent with the device reaching the end of its useful life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the broach corail amt 13 would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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 - 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.Added: a2, a3 h3.

• Brand Name: BROACH CORAIL AMT 13
• Type of Device: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17608288
• MDR Text Key: 321808053
• Report Number: 1818910-2023-17379
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295258155
• UDI-Public: 10603295258155
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2023
• Device Catalogue Number: L20413
• Device Lot Number: SO2002522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male