MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 HUMERAL IMPLANT DRIVER; EXTREMITY INSTRUMENTS : HANDLES

Catalog Number	230783000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
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
Procedure: delta total shoulder prosthesis during the implantation of definitive implant (of the monoblock cemented rod), at the removal of the handle of the humeral implant holder, the impacted device broke: the round platinum pulled off because of 4 broken screws and 2 pulled-off squared plates.The handle broke during a normal use.No discontinuation of the procedure.No change of the surgical technique.No patient consequence.The impacted device was in contact with the patient.
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
Product complaint # (b)(4).Investigation summary during the implantation of definitive implant (of the monoblock cemented rod), at the removal of the handle of the humeral implant holder, the impacted device broke: the round platinum pulled off because of 4 broken screws and 2 pulled-off squared plates.The handle broke during a normal use.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the humeral implant driver found breakage of the 4 screws of the lower plate, causing the cap to fall apart.Broken fragments were returned for evaluation.The potential cause is traced to wear/fatigue of design features and indicates that the failure is attributed to a high cycle fatigue phenomenon, due to slap hammer usage.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 functional test was not performed since it was not applicable to the complaint condition.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 humeral implant driver would have contributed to the complained device 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.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 a manufacturing record evaluation was performed for the finished device product description: humeral implant driver product code: 230783000 lot number: 5312001 and no non-conformances or manufacturing irregularities were identified.Device history batch null.Device history review a manufacturing record evaluation was performed for the finished device product description: humeral implant driver product code: 230783000 lot number: 5312001 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: HUMERAL IMPLANT DRIVER
• Common Device Name: EXTREMITY INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• 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: 20255255
• Report Number: 1818910-2024-19622
• Device Sequence Number: 18013656
• Product Code: HWR
• UDI-Device Identifier: 10603295116363
• UDI-Public: (01)10603295116363(10)5312001
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/19/2024

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: 230783000
• Device Lot Number: 5312001
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 11/27/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/10/2024; 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2018
• 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