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

Catalog Number 217855087

Device Problems Component Missing (2306); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

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 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).

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
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7888759
• MDR Text Key: 120705098
• Report Number: 1818910-2018-69717
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295095361
• UDI-Public: 10603295095361
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 217855087
• Device Lot Number: AH0603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1