MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROX TRIAL SHAFT 75; RECLAIM INSTRUMENTS : FEMORAL TRIALS

Model Number	2975-29-075
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the internal screw of the femoral trial broke into two parts.There was a 20 minute surgical delay.
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
It was also reported that due to a broken test component inside the instruments, dislocation problems occurred at the end of the surgery.Faced with this problem, the surgeon decided to replace the head and insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will bereviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: RECLAIM PROX TRIAL SHAFT 75
• Common Device Name: RECLAIM INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12273755
• Report Number: 1818910-2021-16949
• Device Sequence Number: 4600080
• Product Code: LZY
• UDI-Device Identifier: 10603295156260
• UDI-Public: 10603295156260
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K903084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2021

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: 2975-29-075
• Device Catalogue Number: 297529075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/29/2021; 10/06/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/11/2021; 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1