MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION FE GUIDE SZ 5; FEMORAL TRIALS

Model Number	2504-40-305
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
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
Items damaged: this was discovered upon opening the demo set prior to training.The 4mm offset guide became cross threaded in one of the fe guides, the hex attachment (1.3) was bent as this was attempted to be unscrewed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: ATTUNE REVISION FE GUIDE SZ 5
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11920498
• Report Number: 1818910-2021-11563
• Device Sequence Number: 14270159
• Product Code: HWT
• UDI-Device Identifier: 10603295438540
• UDI-Public: 10603295438540
• 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
• Report Date (Section B): 05/18/2021

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: 2504-40-305
• Device Catalogue Number: 250440305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/10/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1