MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11/130 DEG TI CANN TFNA 170 - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.037.945S

Device Problem Migration (4003)

Patient Problem Ulcer (2274)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. 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) 2022, the tfna hardware was removed due to the implant failing. The implant had cut through and had created an ulcer on the patient¿s lateral side. The implant was intact and no fragments were created. The patient was revised with a total hip arthroplasty (tha). This report involves one (1) 9mm/130 deg ti cann tfna 235mm/left - sterile. This is report 2 of 3 for (b)(4).

• Brand Name: 11/130 DEG TI CANN TFNA 170 - STERILE
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13940100
• Report Number: 2939274-2022-01117
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096548
• UDI-Public: 10886982096548
• Combination Product (y/n): N
• 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: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.037.945S
• Device Catalogue Number: 04.037.142S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown
• Patient Sex: No Answer Provided
• Patient Weight: 66 KG
• Patient Treatment(s): 3.7MM CANNULATED LOCKING SCREW 38MM; TFNA HELICAL BLADE 95MM
• Patient Outcome(s): Required Intervention