MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TIBIAL RESECTION BLOCK 7 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number 249256000

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

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 Description

(b)(4).Software issue.Not recognizing camera when 2.6 knee work flow is selected.Works for knee 3.Reverted to manual instruments when navigation unit didn't work.Loan kit instruments.Dragon tooth tibia.Slot where slap hammer attaches must have a burr as it doesn't release easily.Released when tapped with mallet.7 degree cutting block.One of the holes doesn't accept pin.Must be burred.Picked a different hole which accepted the pin.No adverse events to report.Occurred during surgery.Rep present.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the returned instrument was assessed by depuy australia and the complainants findings confirmed.The assessment was that the complaint was due to wear and tear.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.

• Brand Name: TIBIAL RESECTION BLOCK 7 DEG
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10143834
• MDR Text Key: 230664424
• Report Number: 1818910-2020-13646
• Device Sequence Number: 1
• Product Code: HTZ
• 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,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 249256000
• Device Lot Number: AH033142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1