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).

• 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
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8139384
• MDR Text Key: 129574911
• Report Number: 2939274-2018-55312
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown