MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SP*2 INTRAMED TIB ALIGNMENT DE; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	966315
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
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
Revision right knee replacement , surgeon; (b)(6), (b)(6) hospital (b)(6) 2018.The l shaped assembly could not fit through the alignment device, therefore the jig could not be used.Another instrument kit needed to be used to perform the cuts.No delay to procedure.No ae to patient.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The reported device was not returned for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.

• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7263049
• Report Number: 1818910-2018-53222
• Device Sequence Number: 987378
• Product Code: HWT
• UDI-Device Identifier: 10603295247791
• UDI-Public: 10603295247791
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 966315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1