MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV ADP REM SHAFT LONG; KNEE INSTRUMENT : REAMERS

Model Number	2011-03-029
Medical Device Problem Codes	Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
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
The thread was found to be worn and does not connect to the jig securely.No delay to surgery or patient impact.
Event or Problem Description
Additional information was received indicated that it was a rod that threads into the sleeve allowing a jig to attach to make cuts to the femur.The thread is worn; this mean that the rod does not attach satisfactorily to the sleeve/jig.This means that the jig cannot be attached properly and/or risks being disassociated mid cut or not being able to be used at all.It is the rod alone that has worn thread.No issue with sleeve or jig.
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: the device associated with this report was not returned for evaluation, however, a photo was provided for review.The photo was of poor quality, and no observations pertaining to the nature of the reported event could not be identified.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: lot information not available.

• Brand Name: SIG HP REV ADP REM SHAFT LONG
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11920652
• Report Number: 1818910-2021-11571
• Device Sequence Number: 16961246
• Product Code: LXH
• UDI-Device Identifier: 10603295081487
• UDI-Public: 10603295081487
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/19/2021

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: 2011-03-029
• Device Catalogue Number: 201103029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 08/11/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/23/2021; 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1