MAUDE Adverse Event Report: SYNTHES USA

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: in four (4) patients the imf screws broke in half, all in the same location during insertion after three (3) or four (4) turns.Patient #2, 3, and 4: it was reported by the surgeon three (3) patients had a broken imf screw after three (3) or four (4) turns.The size of the screw is unknown.Patients were all males and were between 20-30 years old.It was noted by the surgeon: another case (patient) he was able to remove a broken 12mm screw.It is not known which of the four patients this report belongs to.This report is on patient #2 with one broken screw.This is 1 of 1 report for complaint (b)(4).

Manufacturer Narrative

This device used for treatment and not diagnosis.Age between 20-30 years old.This report is on an unknown imf screw, part and lot numbers are unknown.Without a part number the 510k number cannot be provided.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Placeholder.

• Manufacturer (Section D): SYNTHES USA; west chester PA 19380
• Manufacturer Contact: sherry laing ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3623912
• MDR Text Key: 18308992
• Report Number: 2520274-2014-00520
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1