MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11/130 DEG TI CANN TFNA 235/LEFT - SILE FEMUR NAIL, STERILE

Model Number 04.037.145S

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 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. 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. Investigation: product was not returned. Based on the information available, it has been determined that no corrective and 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 history review: manufacturing records on product code 04. 037. 145s with lot number 269p911 were reviewed; and all dimensional, visual, sterility and packaging criteria at the time of release were met with no issues documented during the manufacture that would contribute to this complaint condition.

Event Description

This is 1 of 2 for (b)(4). It was reported by the sales rep that on an unknown date, the patient presented with 235mm tfna and non union after 5 months of surgery for an intertroch fracture. There was also a lateral femoral wall fracture below the blade hole. The nail broke at the proximal hole. The nail and blade were removed and revised to a long tfna and lag screw. The status of the patient post hardware removal was unknown. No additional information was provided. This report is for one 11/130 deg ti cann tfna 235/left - sile device. This complaint involves two devices.

• Brand Name: 11/130 DEG TI CANN TFNA 235/LEFT - SILE
• Type of Device: FEMUR NAIL, STERILE
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14250441
• MDR Text Key: 290382273
• Report Number: 2939274-2022-01535
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.037.145S
• Device Catalogue Number: 04.037.145S
• Device Lot Number: 269P911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

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