MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 12MM

Catalog Number 413.012

Device Problems Bent (1059); Break (1069); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 01/31/2012

Event Type  malfunction  

Event Description

The screw does not fix fully into lcp 1/3 tub plate.The plate was contoured and bent with bending irons and subsequently implanted into patient with 3.5mm locking screws length 12mm and length 14mm.The bone was drilled with a 2.8mm drill bit and then measured with a depth gauge before using a hexagonal 2.5 screwdriver to screw in.Final tightening was done with torque limiter and stopped upon hearing one click from the torque limiter.The length of the fibula was not fully restored with the first placement of the plate and required adjustment of plate placement.Upon attempting to remove the screws, the locking 3.5mm screw length 12mm could not be removed.After multiple tries, the surgeon noticed that the recess of the screw head had been damaged due to the amount of force needed to attempt to unscrew the 12mm locking screw.The plate was found to be able to move and spin when the 14mm locking screw was removed from the plate.The 12mm locking screw was seen to be engaged and locked onto the distal fibula instead of the plate.In attempt to remove the screw the plate was bent to act as a screw holder.The vice-grip was used to remove the locking screw from the bone, but was not successful.A conical extraction screw and universal chuck was then used to remove the 12mm locking screw from the bone.No intraoperative imaging was done at the time of the incident.This is 2 of 2 report for event # (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.A review of device history records for manufacturing revealed no complaint related issues.The measurable dimensions of the plate were checked and found to be in compliance with the technical drawings and specifications.The plate was bent and twisted in various directions, according to the existing failure description it can not be determined if this happened before, while or during removal of the plate.Therefore also the threaded locking holes are deformed and not having the exact size anymore.This could be the main source that the locking screw got blocked in the plate.A possible cross threading also could be a reason therefore as the microscopic view shows damaged threads in the plate.Functional test with a locking screw on the only undamaged thread was performed successfully.We were not able to detect a product fault.Placeholder.

• Brand Name: 3.5MM TI LOCKING SCREW SELF-TAPPING 12MM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 4115905
• MDR Text Key: 4841119
• Report Number: 8030965-2014-01274
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 413.012
• Device Lot Number: 2790427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2011
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 28 YR