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

Device Problem Mechanical Jam (2983)

Patient Problem Sedation (2368)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

Device not reportedly explanted.(b)(6).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 the (b)(6) as follows: surgery took place to implant a retrograde antigrade femoral nail (rafn).During one surgery, after finishing the proximal locking, the surgeon tried to remove the jig from the nail by using the screwdriver to undo the jig bolt to the connection of the top of the nail.However it would not disengage and took apparently over an hour to get it out.During a second surgery, this event occurred again when the sales consultant was in a retrograde/antegrade femoral nail case and the jig bolt, jig and nail seemed to lock incorrectly and would not disengage.This may have been caused by soft tissue tensioning on the jig but this was checked before inserting the nail and it seemed to work normal.The nail was hammered in so this could have possibly affected the patient's leg.The patient's leg was adjusted to the adducting position so it could become easier to remove.The release of the jig bolt, jig and nail was still very tight and the procedure was prolonged sixty (60) minutes.There was reportedly no patient harm.This report is for the events that occurred during the second surgery; the events of the first surgery are reported in (b)(4).This report is for one (1) unknown nail.This is report 3 of 3 for (b)(4).

• 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: 5184576
• MDR Text Key: 29733313
• Report Number: 2520274-2015-16890
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 10/13/2015

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2015
• 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