MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC* FLUT TIB ROD TRL 115 X 20; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Catalog Number	866887
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
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
Product name: pfc stem trial extractor; product code: 865226; lot/batch/exp: tbc; was the product being used in a clinical trial? no; did the event happen during a procedure? yes; were you in the procedure at the time of the event? yes; event outcome/how was it managed? broken instrument removed using cold chisel and molegrips.Was there any consequence to the patient due to the event? was the surgery prolonged due to the event? if yes, confirm how many minutes delay ¿ surgery delay was approximately 20 minutes.Has the reporter facility indicated there may be legal action? no.Is the product available for return? yes after cleaning and decon.Please give a detailed explanation of the event: the operation was a distal femur to sleeve case.The surgeon has been using the kit for over 5 years and is a kol and visitation for us.After the trial the surgeon removed the trial components and, as if often the case, in these patients the 31mm sleeve trial and 20 x 115 stem trial disassociated from the trial distal femur.The surgeon inserted the stem trial extractor, attached the slap hammer and tried to remove the trial sleeve and stem.The end of the instrument shear off at the point where the screw thread starts creating a situation where there is no option but to open an additional set of instruments to get a pair of mole grips.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.
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.

• Common Device Name: KNEE INSTRUMENT : TIBIAL STEM TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7717762
• Report Number: 1818910-2018-65137
• Device Sequence Number: 13785272
• Product Code: LXH
• UDI-Device Identifier: 10603295217695
• UDI-Public: 10603295217695
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2018

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: 866887
• Device Lot Number: H0511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/07/2018; 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1