MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE WITH STOPPER 400 MM; PIN, FIXATION, THREADED

Catalog Number	102107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 WITH STOPPER 400 MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8205070
• Report Number: 1020279-2018-02940
• Device Sequence Number: 18887886
• Product Code: JDW
• UDI-Device Identifier: 03596010031259
• UDI-Public: 03596010031259
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 102107
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention