MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.031S

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j employee. (b)(4). 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. 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) 2020, during a hip surgery while doing proximal femoral nailing system (tfna) on a midshaft femur fracture, the fracture was reduced, reamed and implanted using a tfna nail. After getting the tfna nail down the canal, the triple sleeve was used to insert the unknown lag screw. The surgeon proceeded with the steps and inserted the unknown lag screw. The surgeon was unsuccessful in locking the set screw. It was found that the nail disconnected from the unknown aiming arm and the unknown lag screw missed the hole in the nail. The surgeon proceeded to extract the nail and was successful in removing it with the extraction hook. The surgeon opened a new nail and properly assembled it onto the aiming arm before implanting the new nail and unknown lag screw and proceeding with the rest of the case. There was a one hundred twenty (120) minute surgical delay. The procedure was successfully completed. The patient outcome is unknown. This complaint involves six (6) devices. This report is for (1) 10mm/125 deg ti cann tfna 400mm/left ¿ sterile. This is report 1 of 6 for (b)(4).

• Brand Name: 10MM/125 DEG TI CANN TFNA 400MM/LEFT - 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10129285
• MDR Text Key: 194467384
• Report Number: 2939274-2020-02655
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.037.031S
• Device Catalogue Number: 04.037.031S
• Device Lot Number: H225115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 06/08/2020 Patient Sequence Number: 1