MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION TIBIAL BLOCK L; RESECTION BLOCKS/DEVICES

Catalog Number 250610111

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem Not Applicable (3189)

Event Date 05/10/2019

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

Left tibial cutting block was damaged in case.Resident pined tibial cutting block with pin and started the drilling at an angle.This stripped the pin and jammed it in one of the pin holes located on the cutting block.This added roughly 2-3 minutes to the case.They were unable to remove the pin from the cutting block after the cut had been made.They were eventually able to twist the block and pin out of the patient.An insert handle and insert were damaged in the case.The surgeon made a clean up cut with insert and handle in place.Both the insert and insert handle were damaged and tagged.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event of jamming.Depuy considers the investigation closed.Should 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.

• Brand Name: ATTUNE REVISION TIBIAL BLOCK L
• Type of Device: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8653644
• MDR Text Key: 146483394
• Report Number: 1818910-2019-94778
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295436225
• UDI-Public: 10603295436225
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 250610111
• Device Lot Number: SO2027070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1