MAUDE Adverse Event Report: SYNTHES USA 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM; NAIL, FIXATION, BONE

Catalog Number 212.103

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Failure of Implant (1924)

Event Date 03/10/2014

Event Type  Injury  

Event Description

It was reported that the revision procedure occurred in (b)(6) 2014 and all the devices were removed.This is report 2 of 5 for (b)(4).

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient underwent an operation on (b)(6) 2014.The surgery was completed without any problems.In a medical check up the x-ray shows that the screws have backed out of the bone without fracturing the bone.It was also reported that the patient experienced some weight loading.There is an additional surgery scheduled for an unknown date in (b)(6) 2014.This report is for 2 of 3 complaint (b)(4).

Manufacturer Narrative

Explant: (b)(6) 2014; exact date unknown.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.

Manufacturer Narrative

Device used for treatment, not diagnosis additional product code for this report includes; hwc.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 14MM
• Type of Device: NAIL, FIXATION, BONE
• 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: 3731420
• MDR Text Key: 19350003
• Report Number: 2520274-2014-10624
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212.103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2015
• 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
• Patient Age: 53 YR