MAUDE Adverse Event Report: SYNTHES USA 2.0MM IMF SCREW SELF-DRILLING 12 MM; SCREW FIXATION,INTRAOSSEOUS

Catalog Number 201.932

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/21/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during the procedure; the screw was broken during screw connection.There was a report of a ten minute surgical delay.This report is for 1 of 1 complaint (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

A manufacturing evaluation was completed: one broken screw was returned.The screw is not etched (according to the technical drawing), the part number was provided by the complaint handling unit, the lot number is unknown.The screw is broken in the middle of the threaded shaft, both parts, head and tip returned.The relevant features of the part were measured as per the relevant drawing.Threads¿ dimensions and threads¿ geometry meet specification.No anomaly manufacturing related found explaining the screw¿s breakage.Metallurgical analysis has been requested to further investigate the complaint.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.As per received condition of device; the screw is broken about 4mm below the head.The performed investigation could not detect any material faults.The intermaxillary fixation (imf) screw broke according to a ductile forced fracture mechanism.The fine dimple structure on the entire fracture surface and the torsional deformation lines are a clear indication for a ductile forced fracture.Due to the orientation of the ductile honeycombs on the fracture surfaces it can be assumed that the screw was overloaded torsional in fastening direction.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A pd event evaluation was conducted.The report indicates that a safety factor of 1.5 between failure torque and maximum insertion torque was demonstrated by mechanical testing (mt01-161) for the 12mm long stainless steel imf screw.Estimated occurence rate determined to be 0.03%.Pd investigation result: indeterminate.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.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 12 MM
• Type of Device: SCREW FIXATION,INTRAOSSEOUS
• 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: 3792912
• MDR Text Key: 15125305
• Report Number: 2520274-2014-11230
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2014

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: 201.932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 05/06/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/23/2014; 10/15/2014; 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 YR