MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US COMPLETION FEM IMPAC/EXTRACTOR; KNEE INSTRUMENT : EXTRACTION INSTRUMENTS

Catalog Number	217856025
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
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
Surgeon commented that the femoral component holder was not functioning properly.The screw mechanism appeared to be malfunctioning.This did not effect the procedure in any way it was simply being flagged to be replaced once the procedure was completed.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint (b)(4).Investigation summary: no product was returned for investigation despite three requests.The complainant did send a photograph of the instrument but unfortunately the issue could not be determined from the photograph.The instrument was manufactured in sept 2005, making it 14 years old.There is a possibility that the issue is due to normal wear and tear, but without the product to review this cannot be confirmed.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COMPLETION FEM IMPAC/EXTRACTOR
• Common Device Name: KNEE INSTRUMENT : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8621321
• Report Number: 1818910-2019-93932
• Device Sequence Number: 10871708
• Product Code: LXH
• UDI-Device Identifier: 10603295095422
• UDI-Public: 10603295095422
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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 Catalogue Number: 217856025
• Device Lot Number: H0905
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1