MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.037.230S

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

Patient Problems Arthritis (1723); Pain (1994)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, the surgeon removed a tfna nail to convert the patient to a total hip. Patient was in pain and has arthritis of her hip. All tfna implants were removed successfully. Procedure was successfully completed. This report is for one (1) 12mm/125 deg ti cann tfna 400mm/right - sterile. This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. A device history record (dhr) review was conducted: part # 04. 037. 230s, synthes lot # h660112, supplier lot # n/a, release to warehouse date: 13 jun 2018, manufactured by: (b)(4), no ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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.

• Brand Name: 12MM/125 DEG TI CANN TFNA 400MM/RIGHT - 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13620538
• MDR Text Key: 286253990
• Report Number: 2939274-2022-00685
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097163
• UDI-Public: (01)10886982097163
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 04.037.230S
• Device Catalogue Number: 04.037.230S
• Device Lot Number: H660112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 02/28/2022 Patient Sequence Number: 1

Treatment

5.0 TI LOCKING SCREW 80- FOR IM NAILS; LOCKSCR Ø5 SELF-TAP L48 TAN; TFNA SCREW 85MM