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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES TUTTLINGEN LOCKING PLIERS 180MM PLIERS, SURGICAL

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SYNTHES TUTTLINGEN LOCKING PLIERS 180MM PLIERS, SURGICAL Back to Search Results
Catalog Number 391.88
Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Additional narrative: no reported patient involvement. Event date: unknown. Device is an instrument and is not implanted or explanted. (b)(6). Service & repair evaluation: the customer reported the item was not locking properly. The repair technician reported the tip of the lower jaw was damaged. Damaged component is the reason for repair. The item is not repairable. The cause of the issue is unknown. The item will be forwarded for further evaluation. Product investigation summary: the locking pliers is a general surgical instrument available in multiple trauma and spine systems that can be used to bend plates or temporarily fixate a component. The relevant product drawings were reviewed during the investigation and the design, materials, and finishing processes were found to be appropriate for the intended use of the devices. The complaint against the device was that the pliers were not locking properly; however, this complaint was unconfirmed since the device functioned as intended when tested. During the investigation, it was noted that approximately 2mm x smm x o. Smm slab of material was missing from the lower bending jaw of the pliers. Although this damage was not reported in the complaint, a review was conducted based upon the breakage of the device. Service history record review: no service history review can be performed as this is a lot controlled item. The manufacture date of this item is november 3, 2003. The source of the manufacture date is the release to warehouse date. 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.

 
Event Description

Device report from synthes (b)(4) reports an event as follows: it was originally reported that a pair of locking pliers (180mm) were not locking properly. Also, a pair of reduction forceps reportedly had damaged points. The issues were discovered during the cleaning process within the medical device reprocessing department. There was no reported patient or surgical involvement. Upon investigation of the returned devices, however, it was determined that a small fragment of the toothed portion of the locking pliers was missing. Additionally, the tip of the reduction forceps was found to be broken. Based upon this updated information, a reassessment of the reportability was conducted. This report is 1 of 2 for (b)(4).

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. A device history record review was attempted for the subject device lot number but could not be completed due to the age of the instrument. The subject device was manufactured on oct 1, 2003. The previously reported date was the released to warehouse date. Oct 1, 2003 is the actual date of manufacture. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameLOCKING PLIERS 180MM
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
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5504063
MDR Text Key40438648
Report Number9680938-2016-10035
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number391.88
Device LOT Number4675917
OTHER Device ID Number(01)10886982198334(10)4675917
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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