MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US COMPLETION DIST BLK POPUP CAPT; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	217855087
Medical Device Problem Codes	Component Missing (2306); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
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
Right total knee arthroplasty; (b)(6), (b)(6) 2018.During the procedure, the surgeon performed a distal cut on the patient¿s femur using the pop up distal cutting block.At that moment the saw capture came loose and was detached from the block.It appeared to have a screw missing.The surgeon was confident that the screw was missing before commencing with the cut.The scrub nurse and jnj representative were unable to find any screws in the procedure trays.This all happened as the distal cut was completed.There was no adverse event.Patient outcome post surgery: satisfactory outcome as surgeon was able to complete the procedure without any further delay.Female patient id: (b)(6).
Additional Manufacturer Narrative
(b)(4).No device was received.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: COMPLETION DIST BLK POPUP CAPT
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7888759
• Report Number: 1818910-2018-69717
• Device Sequence Number: 11389752
• Product Code: HWT
• UDI-Device Identifier: 10603295095361
• UDI-Public: 10603295095361
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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: 217855087
• Device Lot Number: AH0603
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1