MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA C/R FEM RT SZ3 TRL; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number	96-1013
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
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
It was reported that the femoral lug holes are barbed causing poly shavings to disperse in wound.No surgical delay is noted.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PFC SIGMA C/R FEM RT SZ3 TRL
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10364307
• Report Number: 1818910-2020-17530
• Device Sequence Number: 11345407
• Product Code: HWT
• UDI-Device Identifier: 10603295234647
• UDI-Public: 10603295234647
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 96-1013
• Device Catalogue Number: 961013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1