MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE BAY PT CORT 370 MM; PIN, FIXATION, THREADED

Catalog Number 102102

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/29/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed because the wire snapped on tsf frame at wire fixation bolt interface during patient weight bearing.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.Therefore, a product analysis could not be conducted.After repeated requests, smith and nephew has been unable to obtain device details or confirm the alleged deficiency with the devices.Smith and nephew has an outstanding request with the reporter for information.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch information.Our clinical investigation noted that without supporting clinical/medical documents a thorough investigation cannot be performed.The patient impact could not be determined with the available information.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No further investigation warranted for this complaint; and smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: WIRE BAY PT CORT 370 MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8205055
• MDR Text Key: 131694966
• Report Number: 1020279-2018-02938
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 03596010031204
• UDI-Public: 03596010031204
• Combination Product (y/n): N
• PMA/PMN Number: K994143
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 102102
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention