MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC* FLUT TIB ROD TRL 75 X 12; KNEE TRIAL/INSTRUMENT

Catalog Number	866875
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
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
During a knee revision surgery, the two guardian scions that had the test stem of ct3 were broken and at least one of them remained in the patient, they tried to withdraw but were not able to remove it.For this reason the surgery is delayed about 5 minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.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 will be filed as appropriate.

• Common Device Name: KNEE TRIAL/INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7077890
• Report Number: 1818910-2017-50617
• Device Sequence Number: 685150
• Product Code: LXH
• UDI-Device Identifier: 10603295217572
• UDI-Public: 10603295217572
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 11/06/2017

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: 866875
• Device Lot Number: TBFLV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 07/16/2018; 08/28/2018
• Initial Report FDA Received Date: 12/02/2017
• Supplement Report FDA Received Date: 08/02/2018; 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1