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

Device Problem Sticking (1597)

Patient Problems Bone Fracture(s) (1870); Sedation (2368)

Event Date 03/06/2015

Event Type  Injury  

Event Description

It was reported that the doctor successfully completed the implantation of a tibial nail for a distal 1/3 tibia fracture through a suprapatellar incision with use of the synthes suprapatellar tibial nail instrumentation.However, when trying to remove the insertion handle from the nail with the ball hex screwdriver, the connecting screw would not smoothly disengage from the nail.The driver required a significant amount of force to produce only a quarter turn of the screw.It got to a point where the connecting screw would not turn, so a ratchet wrench was used in conjunction with the ball hex driver.So much force was needed to produce any movement from the screw that by some mechanism an additional fracture (that was not present at the start of the case) was created around the proximal interlock screws at the proximal 1/3 of the tibia.The connecting screw was eventually removed with use of the ball hex driver.An additional proximal screw was placed through the nail by way of perfect circles and the case was completed.There was a sixty (60) minute delay to surgery.This report is for one (1) unknown tibial nail ex.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Patient date of birth and weight are unknown.This report is for one (1) unknown tibial nail ex.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.Device 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.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4610061
• MDR Text Key: 5628743
• Report Number: 2520274-2015-11896
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2015

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?: No
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 03/17/2015
• 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