MAUDE Adverse Event Report: SYNTHES USA IMF SCREW Ø2 L8 SST

Catalog Number 201.928

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

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 #1: two screws broke 8mm and 12mm long.The 8mm screw broke below bone level.Surgeon tried to remove the shaft and was un-successful.Surgeon spent 30 minutes trying to remove the shaft not wanting to damage the tooth root.The shaft of the screw remains in the patients bone.There was significantly prolonged anesthesia.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 #1 with two broken screws.This is 2 of 2 reports for complaint (b)(4).

Manufacturer Narrative

Additional narrative: this device used for treatment and not diagnosis.Age between 20-30 years old.The device was returned and the investigation is ongoing.Placeholder.

Manufacturer Narrative

Additional narrative: manufacturing evaluation was conducted and it states that the tip was broken off.The part was received inside a sterilization bag (the original packaging/labeling was not provided.The screws were not etched (lot numbers unknown).The parts returned were two body screws (from the side of the screw head) and screw tip.The threaded parts showed post production damages.The conclusion of the product investigation is that the complained parts are conforming from a manufacturing perspective.The returned parts were re-inspected and all relevant product features meet specification.No manufacturing related anomaly could be detected.

• Brand Name: IMF SCREW Ø2 L8 SST
• 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: 3623927
• MDR Text Key: 4209869
• Report Number: 2520274-2014-00518
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention