MAUDE Adverse Event Report: SYNTHES USA 1.5MM TI CORTEX SCR SLF-DRLG WITH PLUSDRIVE(TM) RECESS 4MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 400.054E

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 by a sales consultant that there was a complaint against a cmf device.No additional information was provided.No other information reported.Surgeon was performing frontal sinus surgery and three different screws broke intraoperatively.Several fragments were generated as a result.Some of the fragments were able to be retrieved and were discarded.Some of the fragments were left in the patient.The sales consultant was not able to provide specifically how many fragments were discarded and how many were left in the patient as he was not present during the surgery.The surgeon had back up screws available.There was a 20 minute delay in surgery.Surgery was completed successfully.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device broke during insertion; device is not considered implanted/explanted.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.

Manufacturer Narrative

The original awareness date for this event was reported as october 2, 2015 on the initial medwatch in error.The correct date of awareness was october 5, 2015.Device 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: 1.5MM TI CORTEX SCR SLF-DRLG WITH PLUSDRIVE(TM) RECESS 4MM
• 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: 5161891
• MDR Text Key: 28756562
• Report Number: 2520274-2015-16726
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK963546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.054E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention