MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HUMERAL IMPLANT DRIVER; EXTREMITY INSTRUMENTS : HANDLES

Model Number	2307-83-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the impaction of the final stem, the handle broke.Surgical delay of 10 minutes occurred.No adverse affects on the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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.H10 additional narrative: added: d4 (lot), d9 and h4.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).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.H10 additional narrative: added: b5, e1 (initial reporter facility name).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 (clinical code).
Event or Problem Description
Additional information received: a.What part of the humeral implant driver broke? the connection zone with the stem.B.Did it break into two or more pieces? if no, please specify what is the alleged deficiency, is it bent, cracked, stripped, scratched, worn or cross-threaded? yes.C.Was there any adverse consequences that affected the patient because of the reported event? no.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary the device associated with this report was returned to depuy synthes for evaluation.Visual analysis found breakage of the 4 screws of the lower plate thus causing the device to fall apart.The broken part was returned.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was returned to depuy synthes for evaluation.Visual analysis found breakage of the 4 screws of the lower plate thus causing the device to fall apart.The broken part was returned.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: HUMERAL IMPLANT DRIVER
• Common Device Name: EXTREMITY INSTRUMENTS : HANDLES
• 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: 15935001
• Report Number: 1818910-2022-24646
• Device Sequence Number: 20445442
• Product Code: HWR
• UDI-Device Identifier: 10603295116363
• UDI-Public: 10603295116363
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup,Followup
• Report Date (Section B): 12/07/2022

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 Model Number: 2307-83-000
• Device Catalogue Number: 230783000
• Device Lot Number: 5302721
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 12/21/2022; 01/04/2023; 01/06/2023; 02/02/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/22/2022; 01/06/2023; 01/08/2023; 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2017
• 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