MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 BROACH CORAIL AMT 14; HIP INSTRUMENTS : BROACHES

Model Number	L20414
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to connect trial neck segment to broach.Broach neck segment damaged.There was a surgical delay of three minutes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.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 indicating that the surgeon reported the neck segment trial would not connect this broach, broach's neck segment damaged, possibly bent or misshapen through repeated use.Only reported deficiency was on the actual broach portion, the separate neck segment trials are attaching to other broach sizes without issue.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was received for analysis.Visual examination along with photographic evidence of the device, did not confirm the allegation.Functional test was not performed since involved neck trial was not returned for examination.No deformations and/or considerable damages were observed on the broach's post which could cause mating issues.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.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).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: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

• Brand Name: BROACH CORAIL AMT 14
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: amy hendrickson ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 5743674841
• MDR Report Key: 13950759
• Report Number: 1818910-2022-05803
• Device Sequence Number: 14650701
• Product Code: HTQ
• UDI-Device Identifier: 10603295258162
• UDI-Public: 10603295258162
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/30/2022

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: L20414
• Device Catalogue Number: L20414
• Device Lot Number: SO2037166
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 04/05/2022; 05/05/2022; 06/10/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/07/2022; 05/07/2022; 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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