MAUDE Adverse Event Report: SYNTHES (USA); NAIL, FIXATION, BONE

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.This report is for one unknown tibial nail.Part and lot numbers were not available for reporting.Other number¿udi: unknown part number, udi is unavailable.Implant date: unknown date in 2012.Device was not explanted and was removed with the amputated limb.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4).The investigation could not be completed; no conclusion could be drawn by the manufacturer, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 the patient was implanted with a tibia nail and four (4) 4.0 mm locking screws as a result of a gunshot wound to the right leg on unknown date in 2012.It is further reported multiple bullet fragments remained embedded in patient¿s leg.Patient reported pain in the leg.Surgeon reports the pain is caused by the bullet fragments and is unrelated to the implanted device.Patient was returned to surgery on (b)(6) 2016 for the amputation of the leg, with removal of the nail prior to amputation.Surgeon removed two (2) of the screws, and then attempted to connect the extraction screw to the nail for removal.Although numerous attempts were made, surgeon was unable to thread the extraction screw onto the nail.The remaining two (2) screws were then removed and surgeon proceeded with the amputation.The surgery was completed successfully with a delay of approximately 30 minutes.The nail and extraction screw were checked after the procedure and the nail was found to have bony ingrowth, which prevented the extraction screw from connecting to the nail during the procedure.This report is 2 of 2 for (b)(4).

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6129446
• MDR Text Key: 60942738
• Report Number: 2520274-2016-15512
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/03/2016

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/28/2016
• 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
• Patient Age: 32 YR