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

Model Number	2421-09-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
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
The two v-shaped osteotomes in the office moreland set are broken and unusable.This set was delivered this way as loaners.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device was not returned for evaluation, but based on the returned photographs the reported breakage is confirmed.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.

• Brand Name: SHORT V OSTEO 7MM X 7 3/4 IN
• Common Device Name: KNEE INSTRUMENT : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9929486
• Report Number: 1818910-2020-10280
• Device Sequence Number: 19442407
• Product Code: HWM
• UDI-Device Identifier: 10603295122791
• UDI-Public: 10603295122791
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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 Model Number: 2421-09-000
• Device Catalogue Number: 242109000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1