MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.038.195

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.

Event Description

It was reported that on (b)(6) 2022, the surgeon removed one (1) tfna short nail, one (1) tfna screw, and one (1) 5. 0 titanium locking screw with t25 stardrive recess. The patient was infected and the hardware had to be removed. Everything was removed successfully. This report is for one (1) tfna fenestrated screw 95mm. This is report 2 of 3 for complaint (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 95MM
• 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13713964
• MDR Text Key: 286889665
• Report Number: 2939274-2022-00818
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 04.038.195
• Device Catalogue Number: 04.038.195
• Device Lot Number: 470P087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• 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: 03/09/2022 Patient Sequence Number: 1

Treatment

11/130 DEG TI CANN TFNA 170 - STERILE; 5.0 TI LCKNG SCR T25 SD 36 FOR IM NAILS