MAUDE Adverse Event Report: SYNTHES UNKNOWN CABLE WITH CRIMP; CERCLAGE FIXATION

Catalog Number 298.801.01S

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2014 during a distal femur revision surgery, a 4.5mm cortex screw head sheared off during insertion.Additionally, the tensioning device became jammed.The original implant date was (b)(6) 2013.A 4.5 mm variable angle condylar plate was implanted to repair a supracondylar fracture of a distal femur which had both a hip and knee prosthesis.Post-implant x-rays showed a non-union of the femur fracture and a broken plate.The patient was scheduled for revision surgery on (b)(6) 2014 to remove the plate and all screws.A new plate, screws, and a cable would be used to correct the non-union.During the procedure, the head of a cortex screw (part 214.828, lot unknown) sheared off from the shaft during drilling.The shaft could not be retrieved and was left in the patient.Toward the end of the procedure, a cable became stuck in the tightening mechanism of a cable tensioner (part 391.201, lot p507840).An attempt to loosen the tensioner to remove the cable was unsuccessful.The cable had to be cut in order to remove it, and another cable was passed.The procedure was completed successfully without any reported delay.This is report 3 of 3 for the same event, complaint (b)(4).

Manufacturer Narrative

This device is used for treatment, not diagnosis.Investigation could not be completed and no conclusion could be drawn as no device was returned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CABLE WITH CRIMP
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES UNKNOWN
• Manufacturer (Section G): SYNTHES UNKNOWN
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3673140
• MDR Text Key: 4343140
• Report Number: 2520274-2014-10171
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 298.801.01S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/11/2014
• 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 Age: 62 YR
• Patient Weight: 98