MAUDE Adverse Event Report: SYNTHES BETTLACH MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C; SCREW FIXATION, INTRAOSSEOUS

Catalog Number 04.503.104.04S

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2014

Event Type  malfunction  

Event Description

The surgeon attempted to secure the burr cover hole to the patient's skull using the matrix neuro screw, but the lower part of screw head was broken.The screw shaft remained in the patient's bone.No further information was available at the time of this report.This is report 1 of 1.(b)(4).

Event Description

Device report from synthes (b)(4) reports an event in (b)(6).

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.Investigation could not be completed and no conclusion could be drawn as no device was returned a review of the device history records no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.This device was used for treatment and 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

Additional narrative: additional information: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Additional narrative: device broke during insertion and was not implanted/explanted.A manufacturing evaluation was completed: the screw was received broken screw; just the head of the screw was returned.The investigation of the complained screw could not identify the exact root cause.This is very delicate implant which requires extra caution during use.It is possible that the presented screw broke according to a ductile forced fracture during insertion by applying a high torsional load.A reason for an intra-operative failure for the matrixneuro screw could be insertion of the screw in an exceptional hard bone without pre-drilling.The manufacturing records were reviewed and no complaint related issues for this article and lot number were found.No product fault could be detected.Device broke during insertion and was not 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.

• Brand Name: MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
• Type of Device: SCREW FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3699019
• MDR Text Key: 4262757
• Report Number: 9612488-2014-10063
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 04.503.104.04S
• Device Lot Number: 8434073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• Type of Device Usage: Unknown
• Patient Sequence Number: 1