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

Catalog Number 991016

Device Problem Material Twisted/Bent (2981)

Patient Problem Not Applicable (3189)

Event Date 11/28/2018

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

Modified hudson adaptor did not hold reamer and kept slipping off.Same issue with the t-handle.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.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.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8196105
• MDR Text Key: 131468692
• Report Number: 1818910-2018-79094
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295253617
• UDI-Public: 10603295253617
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 991016
• Device Lot Number: H1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR