MAUDE Adverse Event Report: SYNTHES USA TFNA HELICAL BLADE 105MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.305S

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and 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 during a trochanteric femoral nailing advance system (tfna) procedure for an inner trochanteric fracture the blade was in less than optimal position.The nail and blade was inserted without difficulty and the nail lock was engaged to prevent blade rotation.As the surgeon compressed the fracture by turning the buttress compression nut an audible noise was heard.The surgeon visualized the fracture through fluoroscopy and identified that the blade was pulled back from the initial position about five millimeters.The surgeon was satisfied with the fracture compression and did not correct the position of the blade.There was less than a three minute surgical delay.The patient's outcome was fine.This complaint involves one devices.Concomitant devices reported: buttress compression nut (unknown part/lot number.Quantity 1) and tfna long nail (part number 04.037.160s.Quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).Partial udi number: (b)(4).Device 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: TFNA HELICAL BLADE 105MM 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: 5667933
• MDR Text Key: 45578079
• Report Number: 2520274-2016-12771
• 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: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.305S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• 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
• Patient Age: 82 YR