MAUDE Adverse Event Report: SYNTHES USA 12MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.212S

Device Problem Material Deformation (2976)

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

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported the patient underwent a surgery for femoral trochanteric fracture on (b)(6) 2016.The surgeon took out a connecting screw.Through the insertion handle, he tried to insert the 0mm end cap; however he couldn¿t insert the end cap properly since the skin incision was too small.Then he tried to insert the end cap without the insertion handle.He inserted the end cap but in the process he heard some strange noise.When the surgeon took x-rays, he noticed the click on the nail was distorted outward.The image showed something like wire came out of the proximal nail.The surgeon rectified the distorted click by using forceps.Surgery was completed successfully with a one (1) minute delay.There is no information available about patient outcome.Concomitant device: 0mm end cap (part likely 04.038.000s, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional concomitant devices reported: connecting screw (part # unknown, lot # unknown, qty 1).Insertion handle (part # unknown, lot # unknown, qty 1).

• Brand Name: 12MM/125 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6139453
• MDR Text Key: 61302181
• Report Number: 2520274-2016-15544
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.212S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 PART LIKELY 04.038.000S, LOT UNKNOWN,0MM END CAP