MAUDE Adverse Event Report: SYNTHES (USA) TFNA HELICAL BLADE 90MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.290S

Device Problem Positioning Problem (3009)

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

Event Date 04/24/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.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.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 there was a positioning issue with a trochanteric fixation nail - advanced (tfna) blade during surgery on (b)(6) 2016.During surgery to treat a femur fracture, the nail and blade were already implanted, the surgeon tried to use the compression nut and as he tried to spin it to gain compression, the blade pulled out of the medial segment of bone (i.E.The femoral head).The distance from the tip of the blade to the subchondral bone in the femoral head had an undesired increase.A popping sound was heard, but the cause undetermined.Traction was taken off at the point.It was noted it should have been removed earlier.Some compression was gained through continued turning of the compression nut, as well as through mallet strikes on the coupling screw.The blade, nail and screws were left implanted in patient, and no instruments were loose or were retained in the patient.The surgical delay was less than three minutes.The patient's condition was stable at the end of the surgery and the procedure was completed successfully.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA HELICAL BLADE 90MM STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5653880
• MDR Text Key: 45156739
• Report Number: 2520274-2016-12681
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.290S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2016
• 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: (B)(4), 3.2MM WIRE GUIDE SLEEVE