MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.056S

Device Problems Failure to Align (2522); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth and weight were not provided for reporting. Device was implanted on (b)(6) 2018 and remained implanted. Device explant date is not applicable. Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. 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) 2018, patient underwent surgery. During the surgery, while using the hip tfna nail, the surgeon went to take the locking mechanism of the nail down and it wouldn¿t budge. They were unable to see on the x-rays whether the nail was up or down, so they had to take the blade and nail out and put them back in again. This time, the locking mechanism moved without a problem. Due to this, twenty-five (25) minutes were added to the procedure. The procedure was completed successfully with no harm to the patient. Concomitant devices reported: helical blade (part# unknown, lot# unknown, quantity 1). This report is for one (1) 10mm/130 deg ti cann tfna 360mm/right ¿ sterile. This is report 1 of 1 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - 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: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7440255
• MDR Text Key: 106078980
• Report Number: 2939274-2018-51806
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096128
• UDI-Public: (01)10886982096128
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/01/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 04.037.056S
• Device Catalogue Number: 04.037.056S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/01/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown