• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES TUTTLINGEN MATRIXMANDIBLE COMBINATION BENDER PLIERS,SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES TUTTLINGEN MATRIXMANDIBLE COMBINATION BENDER PLIERS,SURGICAL Back to Search Results
Catalog Number 03.503.056
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device used for treatment, not diagnosis. No patient involvement reported. Device is an instrument and is not implanted/explanted. Date returned to manufacturer. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records review was conducted. The report indicates that the: manufacturing date: 15-may-2009. Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A review of inspection records and certifications, confirm that the components and final product met inspection records. All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on 14-may-2009. The screws were secured in three places also on the 14-may-2009. No ncrs were generated during production. 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 while refilling and assembling a matrix mandible set, it was noticed the spot welded screw in the matrix mandible combination bender had broken and the screw was backing out. No patient involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. A product investigation was performed. It was reported that while refilling and assembling a matrix mandible set, it was noticed the spot welded screw in the matrixmandible combination bender had broken and the screw was backing out. No patient involvement. This complaint is confirmed. The m6 screw component (part# 03_503_056_3) has sheared in half. The proximal portion still remains captured in the handle but the distal end (which was staked to the handle in 3 places) has sheared off mid-thread and was not returned to cq. The diameter of the screw at the location of breakage could not be measured during this investigation as it is not accessible (recessed in the device). This was most likely due to application of excessive force, aggressive or mishandling. A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMATRIXMANDIBLE COMBINATION BENDER
Type of DevicePLIERS,SURGICAL
Manufacturer (Section D)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6408369
MDR Text Key70321516
Report Number9680938-2017-10043
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number03.503.056
Device LOT NumberT936274
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/02/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/15/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-