MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SHORT V OSTEO 7MM X 7 3/4 IN; KNEE INSTRUMENT : CUTTING INSTRUMENTS

Catalog Number	242109000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
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.
Event or Problem Description
It was reported that the surgeon broke the instruments while using them to protocol.Temporarily used the received date (b)(6) 2017 as an event date and alert date.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the submitted device confirms the reported event.Device history lot: null.Device history lot: null.Device history review: null.

• Brand Name: SHORT V OSTEO 7MM X 7 3/4 IN
• Common Device Name: KNEE INSTRUMENT : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 7061364
• Report Number: 1818910-2017-50269
• Device Sequence Number: 1824365
• Product Code: HWM
• UDI-Device Identifier: 10603295122791
• UDI-Public: 10603295122791
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/31/2017

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: 242109000
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR