MAUDE Adverse Event Report: SYNTHES USA 4.9MM TI LOCKING BOLT 36MM; PIN,FIXATION,SMOOTH

Catalog Number 459.360

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 02/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).(b)(4) the patient undergoing revision surgery to remove misaligned device.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 (b)(4) reports an event in (b)(6) as follows: on (b)(6) 2016, during proximal femoral nail (pfn) surgery, the surgeon experienced issues when drilling the distal locking bolt through the green sleeve assembly and the 125 degree aiming jig for pfna whereby the drill bit was reported to have been catching on the nail once through the near cortex.A 4.9 mm locking bolt was inserted once the bone was drilled.The next day, the surgeon reviewed post-operative x-rays and found that the locking bolt had missed the aperture of the nail, thus the nail was not locked distally.The patient returned to the operating room on (b)(6) 2016 and the distal locking bolt was removed and a new bolt was inserted through the nail.This is report 1 of 5 for (b)(4).

• Brand Name: 4.9MM TI LOCKING BOLT 36MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5501916
• MDR Text Key: 40386993
• Report Number: 2520274-2016-11664
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• 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 Outcome(s): Required Intervention