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

Catalog Number 459.360

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that a proximal femoral nail antirotation (pfna) was implanted 4 months ago in india and was causing patient pain related to prominence of the device and delayed healing.All of the hardware was removed and replaced with a trochanteric fixation nail (tfn).Reportedly when trying to remove end cap; the blade bent during surgery.No surgical delays were reported or patient harm.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Original implant date reported only as 2014 approximately 4 to 5 months prior to this report.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.

• 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: 4332819
• MDR Text Key: 17264777
• Report Number: 2520274-2014-15365
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 459.360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/16/2014
• 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