MAUDE Adverse Event Report: SYNTHES (USA) TI MATRIXMIDFACE EMERGENCY SCREW 6MM; SCREW FIXATION,INTRAOSSEOUS

Catalog Number 04.503.236.01S

Device Problem Material Separation (1562)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the surgeon implanted screws and when he tried to remove them from the plate to readjust the plate, the head of the screw snapped off both of the screws.No adverse outcome to the patient was reported.An additional three to five minutes was added to the surgery due to this event.This report is for 1 screw.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional common device name jey.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.Without a lot number the device history records review could not be completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4): a review of the device history records was completed for both lot numbers: no non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A manufacturing evaluation was completed: our investigation shows that two screws were sent back.The screw, article 04.503.205.04s, is worn out at the screw recess.Only a screw recess fragment of article 04.503.236 is available.The broken part is missing.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the received information we can not determine the exact root cause.It is likely that exceeding applied torsional force while use (with a possible damaged screwdriver) has lead to these damages.Unfortunately the screwdriver itself was not returned for investigation.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.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: TI MATRIXMIDFACE EMERGENCY SCREW 6MM
• 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: 3818460
• MDR Text Key: 4391937
• Report Number: 2520274-2014-11543
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050608
• 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: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.236.01S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1