MAUDE Adverse Event Report: SYNTHES USA; TRAY, SURGICAL INSTRUMENT

Device Problem Fitting Problem (2183)

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

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown conical extraction screw/unknown lot.Part and lot number are unknown; udi number is unknown.Per technique guide, the likely part number for this device is 387.34.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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

It was reported that on (b)(6) 2016 a surgeon performed an anterior cervical discectomy and fusion (acdf) using non-synthes devices.The surgeon was also performing a partial removal of a previously implanted synthes device as part of the patient's treatment plan.The surgical plan was to remove one of the two-part screws used to secure a previously implanted synthes cervical spine locking plate (cslp).The plate was implanted at level c3-4 during a previous anterior cervical discectomy and fusion (acdf).The screw affixed to this plate (at level c-4) was a two-part expansion screw.It was reported that after removing the first part of the device (the inner screw), the surgeon tried to remove the second part of the device (the outer screw) using the recommended driver but the screw would not back out.The surgeon then tried to remove the screw using a 1.5mm set screw extractor.After inserting the extractor, the tip broke off.An unknown screwdriver was used and eventually the screw was removed.It was reported that the surgery was delayed by approximately thirty (30) minutes due to the screw being difficult to remove.It was reported that it is unknown if the patient required any additional medical intervention like anesthesia.The reporter was not aware of any adverse consequence to the patient.This report is for an unknown conical extraction screw.This is report 2 of 2 for (b)(4).

• Type of Device: TRAY, SURGICAL INSTRUMENT
• 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: 5531245
• MDR Text Key: 41318787
• Report Number: 2520274-2016-11852
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• 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?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1