MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 110MM ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, the trochanteric femoral nail advance (tfna) hardware was removed due to a femoral neck fracture. Both the tfna nail and locking screws were not broken. The patient was revised/replaced with a hemi-arthroplasty. There was an unspecified surgical delay. Procedure and patient outcome are unknown. This report is for one (1) tfna fenestrated screw 110mm. This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report. Additional device procode: ktt. Device is not expected to be returned for manufacturer review/investigation. Concomitant devices are non applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA FENESTRATED SCREW 110MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8206428
• Report Number: 2939274-2018-55645
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098801
• UDI-Public: (01)10886982098801
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 04.038.210
• Device Catalogue Number: 04.038.210
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/29/2019

Is This a Reprocessed and Reused Single-Use Device?

• Patient Outcome(s): Required Intervention