MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROXIMAL TIBIAL RESECT GUIDE; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number 2490-46-000

Device Problems Break (1069); Material Twisted/Bent (2981); Naturally Worn (2988); Physical Resistance/Sticking (4012)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 02/25/2020

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

Broken and worn tibial jig lcs.Would not extend during surgery, locking mechanism was jammed, 10 minute delay whilst alternative kit sourced.Pin puller the spring has worn and a new one is required.

Manufacturer Narrative

H10 additional narrative: product complaint #
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> pc-(b)(4).Investigation summary
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> no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).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.Follow up information provided determines that the instrument was not broken.Physical resistance between the clamp and the rod.

Event Description

Additional information received that the threaded connection between the spiked proximal rod and the tibial alignment jig became stuck and would not allow movement of the rod to position correctly.

• Brand Name: PROXIMAL TIBIAL RESECT GUIDE
• 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: 9823906
• MDR Text Key: 183152077
• Report Number: 1818910-2020-07587
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295125884
• UDI-Public: 10603295125884
• 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,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2490-46-000
• Device Catalogue Number: 249046000
• Device Lot Number: AY1095F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1