MAUDE Adverse Event Report: SYNTHES USA 2.0MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE; BONE PLATE

Catalog Number 806.006.02S

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528)

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

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.(b)(4).Device was not implanted/explanted.(b)(6).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.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported surgery of jaw deformity was performed to the patient's mandibular.When the surgeon attempted to insert the reported screw to fix the plate, the screw did not stop being inserted due to no resistance.The surgeon had difficulty removing the screw, but he could finally extract the reported screw using tweezers.The surgeon eventually used an emergency screw instead to complete the fixation.No surgical delay was reported.No adverse consequences were reported.This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM RAPID RESORBABLE CORTEX SCREW 6MM-STERILE
• Type of Device: BONE PLATE
• 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: 5200456
• MDR Text Key: 30345546
• Report Number: 2520274-2015-17044
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK062789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 806.006.02S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• 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