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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES TUTTLINGEN LOCKING PLIERS-LONG PLIERS,SURGICAL

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SYNTHES TUTTLINGEN LOCKING PLIERS-LONG PLIERS,SURGICAL Back to Search Results
Catalog Number 359.224
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Part number: 359. 224, synthes lot number: t941517: release to warehouse date: (b)(6) 2009. Mfg. Site: monument. No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. 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 on (b)(6) 2016, during sterile processing, the locking pliers - long were found to have a portion broke off where the locking mechanism is located. The date of the breakage is unknown. There was no patient involvement reported. This is report number 1 of 1 for (b)(4).

 
Manufacturer Narrative

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

Device was used for treatment, not diagnosis. The 359. 224 lot number t941517 locking pliers were returned and reported to have become broken. A visual inspection, functional test, and drawing review were performed as part of this investigation. This condition is confirmed; a pin within the locking mechanism has broken off and was not returned causing another component of the locking mechanism to become detached. The device was manufactured in 12/2009 and is over six years old. The balance of the returned device is in fairly worn condition with several markings and other signs of wear along its length. All measurements have been performed by calipers. Whether the complaint condition for this device can be replicated is not applicable for this condition. The 359. 224 locking pliers are an instrument routinely used in the titanium elastic nail system (per technique guide). Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. This complaint condition was likely caused by over six 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. A corrected device history record review was performed. Review of the device history record 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 critical features and for function at the final inspection on 04-dec-2009. No nonconformances 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.

 
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Brand NameLOCKING PLIERS-LONG
Type of DevicePLIERS,SURGICAL
Manufacturer (Section D)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen CO 78532
GM 78532
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen CO 78532
GM 78532
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5955707
MDR Text Key54998002
Report Number1719045-2016-10686
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 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup,Followup
Report Date 09/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number359.224
Device LOT NumberT941517
OTHER Device ID Number(01)10886982197252(10)T941517
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2009
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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