MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.042S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

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 (b)(6) 2018, during a revision surgery of a trochanteric femoral nailing advanced (tfna) system, the surgeon had difficulty locking the tfna screw to the nail. The surgeon inserted the lag screw to the nail and locked the set screw in the nail. Then when he tried to rotate the lag screw, he was only able to rotate it 180 degrees. The steps were repeated, and the set screw was finally locked. It is unknown if there were any surgical delays. The procedure was successfully completed. The patient outcome is unknown. Concomitant devices reported: locking screw (part# 04. 005. 528s, lot# unknown, qty 1); tfna screw 95mm (part# 04. 038. 095s, lot# unknown, qty 1); this report is for one (1); 10mm/130 deg ti cann tfna 170mm - sterile. This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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. Initial reporter: state and country code. 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: 10MM/130 DEG TI CANN TFNA 170MM - STERILE
• 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: 8139384
• MDR Text Key: 129574911
• Report Number: 2939274-2018-55312
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982095985
• UDI-Public: (01)10886982095985
• 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: 10/03/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.037.042S
• Device Catalogue Number: 04.037.042S
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/31/2018

Is This a Reprocessed and Reused Single-Use Device?