MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SPEC* ALIGNMENT ROD; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number 991016

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.

Event Description

Total knee replacement - external alignment rod on sigma pfc spec 2 instrument tray was bent.Unable to use to double check intramedullary alignment.Patient was unaffected, surgeon carried on with procedure.No delay in surgery.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search made over the previous 10 years found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search made over the previous 10 years found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.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.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 : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8325919
• MDR Text Key: 135723594
• Report Number: 1818910-2019-83969
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295253617
• UDI-Public: 10603295253617
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 991016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR