MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 BROACH CORAIL AMT 12; HIP INSTRUMENTS : BROACHES

Model Number	L20412
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.
Event or Problem Description
It was reported that the neck trials would not fit down on the broach.The calcar plane was also reported to be blunt.
Event or Problem Description
Additional information received.A.What was the exact allegation against the device? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction? -neck would not seat flush on the broach b.Was there a surgical delay? if yes, what is the duration of the delay? -yes, estimated 10-15miniuts c.Was there any adverse consequences that affected the patient because of the reported event? -none reported d.Was there any allegation against the neck trials? -no as the neck trial fitted on other broaches.
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, d4 (lot), h4, h6 health effect - impact code 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 today the employee used a corail hip stem and had an issue with the size 12 broach.It appears that the neck trials would not fit down on the broach please see photos attached of the problem parts and corail set.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 today the employee used a corail hip stem and had an issue with the size 12 broach.It appears that the neck trials would not fit down on the broach please see photos of the problem parts and corail set.Please can we replace this broach and ensure it is not re issued.The calcar plane was also reported to be blunt.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection found the de post with deep circular scratches and worn down.The observed condition was consistent as an end of life indicator; damage consistent with repeated use and servicing.A dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test was performed with the returned mating component and they were not able to assemble correctly.The observed damage can be attributed to the inability to assemble.The overall complaint was confirmed as the observed condition of the [broach corail amt 12] 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 a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (a0108) provided is not a valid finished goods lot.
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.

• Brand Name: BROACH CORAIL AMT 12
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17327265
• Report Number: 1818910-2023-14360
• Device Sequence Number: 20214648
• Product Code: HTQ
• UDI-Device Identifier: 10603295258148
• UDI-Public: 10603295258148
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 07/14/2023

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: L20412
• Device Catalogue Number: L20412
• Device Lot Number: A0108
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 08/28/2023; 11/14/2023; 11/21/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 07/24/2023; 08/28/2023; 11/20/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2008
• 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