MAUDE Adverse Event Report: SYNTHES USA T-HANDLE WITH QUICK COUPLING; TAP, BONE

Catalog Number 311.44

Device Problem Bent (1059)

Patient Problems Bone Fracture(s) (1870); Discomfort (2330); Sedation (2368)

Event Date 04/29/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event as follows: it was reported that the surgeon encountered a cold welding between the plate and screws during a revision procedure involving a tomofix tibial osteotomy plate.The revision itself was a planned procedure following patient reports of discomfort post healing/union.During the revision, it was discovered that two (2) proximal screws and one (1) distal screw had cold-welded to the plate.There was reportedly no other way to remove these screws than to drill the screw heads and use a broken-screw removal set.The two (2) proximal screws were explanted via the broken-screw removal set.While trying to remove the distal screw, however, the t-handle just twisted.The conical extraction screw broke within the screw head.A high speed steel (hss) drill bit was then used to dull the screw head, but that did not work as it was worn.The surgeon then tried to free the screw with the use of a hammer and a chisel.A final attempt to remove the screw was made with an osteotomy between the plate and the bone.This caused the screw head to break and a tibial fracture to occur (a chunk of the patient¿s bone was removed with the screw).The fracture ended up pushing out the remaining portion of the distal screws.As a result of the iatrogenic fracture, the surgeon had to perform an open reduction internal fixation (orif).The other screws were removed with no difficulty.The procedure was delayed by thirty (30) minutes.Patient status/outcome is reported as ¿fine.¿ this report is 5 of 9 for (b)(4).

Manufacturer Narrative

Patient weight is unknown.Device is an instrument and is not implanted or explanted.Per facility, the complainant part was discarded and is not available for investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

• Brand Name: T-HANDLE WITH QUICK COUPLING
• Type of Device: TAP, 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: 4781969
• MDR Text Key: 20360858
• Report Number: 2520274-2015-13981
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR