MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SPECIALIST*2 REFERENCE GUIDE; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	966530
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation: company rep.
Event or Problem Description
Instrument was reported to have been bent.
Additional Manufacturer Narrative
B)(4).Investigation summary = > the device associated with the reported event was not returned for evaluation.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 will be filed as appropriate.

• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8616071
• Report Number: 1818910-2019-93668
• Device Sequence Number: 3236780
• Product Code: HWT
• UDI-Device Identifier: 10603295248668
• UDI-Public: 10603295248668
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 966530
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1