MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 / TI CANN FRN / GT 360 / LEFT - SILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.033.967S

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2022, during a routine frn nail insertion, the im nail got stuck in the canal of the femur. The canal 1. 5mm reamed over the nail diameter and opened the proximal segment with the appropriate 14mm drill bit from the set. The nail became incarcerated upon insertion and the proximal body of the nail seemed to be too long for the proximal segment of the femur on this patient. The driving cap broke off leaving a fragment in the insertion handle due to incarceration that led the surgeon to have to strike the insertion handle to seat the nail. The surgeon determined that the nail was finally seated to a depth after a 30 min delay. Standard locking of the proximal and distal nail occurred without incident. This report is for one (1) 9 / ti cann frn / gt 360 / left - sile. This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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.

• Brand Name: 9 / TI CANN FRN / GT 360 / LEFT - SILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14254562
• MDR Text Key: 290449475
• Report Number: 2939274-2022-01570
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.033.967S
• Device Catalogue Number: 04.033.967S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/29/2022 Patient Sequence Number: 1

Treatment

DRIVING CAP/THREADED.; RADIOLUCENT INSERTION HANDLE FRN; UNK - SCREWS: NAIL DISTAL LOCKING.; UNK - SCREWS: NAIL PROXIMAL LOCKING.