MAUDE Adverse Event Report: SYNTHES USA IMF SCREW Ø2 L12 SST

Catalog Number 201.932

Device Problems Break (1069); Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported on (b)(6); that during the surgery on (b)(6) 2013 a intramedullary fixation screw ø 2.0 mm, length 12 mm was beheaded.It was reported that the patient had fracture of the mandibular body.The screw broke in his head, so the surgery was delayed in minutes to remove broken screw left inside the patient.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an implant.Investigation could not be completed and no conclusion could be drawn as no device was returned.A review of device history records was not performed the lot number was not provided.Placeholder.

• Brand Name: IMF SCREW Ø2 L12 SST
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: gabriel szasz ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3552029
• MDR Text Key: 3981318
• Report Number: 2520274-2013-08043
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K010527
• 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
• Report Date: 12/19/2013

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: 12/19/2013
• Initial Date FDA Received: 01/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 28 YR