MAUDE Adverse Event Report: SYNTHES (USA) IMF SCREW Ø2 L12 SST; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 201.932

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported, during a procedure to correct fractures on a patients teeth, cerclage was performed on the patients left side then released.The resident placed an imf screw 2.0x12mm in the lower jaw, while turning the screw, the screw broke.The doctor attempted to place another screw of the same length again in the same part of jaw and the screw broke without exerting force or lever.Finally the doctor placed an imf screw 8mm 2.0x and it worked.The fragments of the broken screws remained within the lower jaw of the patient.Per additional information received march 18, 2014 the patient is in good condition, there was not a prolongation of surgery.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device used for treatment not diagnosis (b)(4).The part was not returned for evaluation.The lot number is unknown therefore a review of the device history record could not be completed.No conclusion could be drawn, as the part was not received.

• Brand Name: IMF SCREW Ø2 L12 SST
• 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: 3710008
• MDR Text Key: 4333801
• Report Number: 2520274-2014-10515
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 03/28/2014
• 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