MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 P.F.C.* PRESS-FIT ROD WRENCH; KNEE INSTRUMENT : WRENCHES

Catalog Number 865189

Device Problem Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 02/11/2019

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

A sigma knee revision was done on a patient on monday (b)(6) 2019 and the x-rays were shown to the sales agent on (b)(6) 2019.X rays show the tibial baseplate, metaphyseal sleeve and the universal stem are show coming through the coritcal bone of the tibial shaft.The event was believed to occur as intra-op, we had problems going down the tibial shaft due to a cement plug or a plug of some sort not allowing us to go straight down the tibial canal and forcing us to go down on an angle until the reamers came out of the tibial canal and through cortical bone.

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 #
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> (b)(4).Investigation summary
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> the device associated with the reported event was not returned for evaluation.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, a follow-up medwatch will be filed as appropriate.

• Type of Device: KNEE INSTRUMENT : WRENCHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8575366
• MDR Text Key: 143944930
• Report Number: 1818910-2019-92362
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295216759
• UDI-Public: 10603295216759
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 865189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1