MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC* FLUT TIB ROD TRL 75 X 16; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Catalog Number	866877
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device found the threads of the mating device broken off and lodged in the mating feature.There is no evidence device malfunctioned and any damage was secondary to the mating device.Depuy synthes considers the investigation closed at this time.Should the 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.
Event or Problem Description
Extraction screw found broken in trial.Patient consequence? no.Patient consequence description: not used during the case.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device found the threads of the mating device broken off and lodged in the mating feature.There is no evidence device malfunctioned and any damage was secondary to the mating device.Depuy synthes considers the investigation closed at this time.Should the 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, a follow-up medwatch will be filed as appropriate.

• Common Device Name: KNEE INSTRUMENT : TIBIAL STEM TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8199722
• Report Number: 1818910-2018-79203
• Device Sequence Number: 19353108
• Product Code: LXH
• UDI-Device Identifier: 10603295217596
• UDI-Public: 10603295217596
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 866877
• Device Lot Number: H0507
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 12/28/2018
• Patient Sequence Number: 1