• 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 BENDING/CUTTING PLIERS 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 BENDING/CUTTING PLIERS PLIERS,SURGICAL Back to Search Results
Catalog Number 391.962
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Additional narrative: date device was chipped is not known. Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. The customer reported the jaw inserts needed replacing. The repair technician reported the jaws had a chip missing out of them. Damaged component is the reason for repair. The item is not repairable per the inspection sheet. The cause of the issue is unknown. The item will be forwarded to customer quality. The evaluation was confirmed. Part 1 of 1. No service history review can be performed as part number 391. 962 with lot number(s) t942349 is a lot/batch controlled item. The manufacture date of this item is 15-dec-2009. The source of the manufacture date is the release to warehouse date. The service history review is unconfirmed. 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 11-dec-2009. No ncrs were generated during production. Manufacturing date: 11-dec-2009. 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 the jaw inserts of the bending/cutting pliers needed to be replaced. During the service evaluation of the device it was noted the jaws had a chip missing. There was no reported patient or procedure involvement. This report is for one (1) bending/cutting pliers. This is report 1 of 1 for (b)(4).

 
Manufacturer Narrative

Additional narrative: a product investigation was performed on the returned subject device. A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation. This complaint is confirmed. The 391. 962 lot number t942349 bending/cutting pliers were returned and reported to need jaw inserts to be replaced. This complaint condition was likely caused by over seven years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency. The 391. 962 bending/cutting pliers is an instrument routinely used in the 2. 7mm variable angle locking calcaneal plating system per relevant technique guide. The device was returned and reported to need jaw inserts to be replaced. This condition is confirmed; one of the inserts inside the device jaws is missing two small fragments that are each approximately a millimeter square. The device was manufactured in 12/2009 and is over seven years old. The balance of the returned device is in fairly worn condition with some superficial wear. Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. The condition of the returned device does agree with the complaint description. Whether the complaint condition for this device can be replicated is not applicable for this condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBENDING/CUTTING PLIERS
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 Key6474186
MDR Text Key72277545
Report Number9680938-2017-10063
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 02/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number391.962
Device LOT NumberT942349
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/09/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/11/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-