MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 SP*2 INTRAMED TIB ALIGNMENT DE; KNEE INSTRUMENT/TRIAL

Catalog Number	966315
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the tibial instrument has a small screw that has gone missing.
Additional Manufacturer Narrative
The device associated with this reported event was not received for examination.Depuy considers the investigation closed.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 will be filed as appropriate.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The device associated with this reported event was not received for examination.Depuy considers the investigation closed.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 will be filed as appropriate.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Examination of the returned device confirmed the reported missing component.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/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6915045
• Report Number: 1818910-2017-25918
• Device Sequence Number: 16264130
• Product Code: HWT
• UDI-Device Identifier: 10603295247791
• UDI-Public: 10603295247791
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/05/2017

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: GM0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/23/2017; 10/31/2017; 11/29/2017; 11/30/2017; 04/30/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/25/2017; 11/23/2017; 12/05/2017; 12/06/2017; 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1