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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES TUTTLINGEN COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES PLIERS, SURGICAL

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SYNTHES TUTTLINGEN COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES PLIERS, SURGICAL Back to Search Results
Catalog Number 391.965
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2017
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. The subject device has been received and is currently undergoing investigation. A device history record review was performed for the subject device lot. Manufacturer: synthes (b)(4). Date of manufacture: nov 11, 2005. The review showed that there were three (3) different manufacturing lots under a7oa45: ba# 903322, ba# 903324, and ba# 903316. The review of all three lots showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. 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 during a mid-face orbital floor blowout procedure on (b)(6) 2017, while the surgeon was bending the plate on the back-table, the tension spring broke near the main frame of the combination bending/cutting pliers and fell out. The surgeon easily retrieved the spring. Since this event occurred at the back table, the spring did not fall into the patient¿s wound. The surgeon finished the procedure with a readily available back-up device. There was no surgical time delay or harm to the patient. Concomitant medical products: unknown plate - part# - unknown, lot# - unknown, quantity# - 1. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

Product development investigation has been completed. A visual inspection, drawing review and dhr review were performed as part of this investigation. The complaint is confirmed. Replication of the complaint condition is not applicable as the device is already broken. The combination bending/cutting pliers were confirmed to have a broken leaf spring. The spring broke where it is screwed into the handle. The device shows normal surface wear from over 11 years of use. Relevant drawings were reviewed. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned parts were determined to be suitable for the intended use when employed. No definitive root cause was able to be determined. The device is over 11 years old and the leaf spring likely weakened due to numerous use and sterilization cycles. 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.

 
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Brand NameCOMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES
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 Key6390210
MDR Text Key69444609
Report Number9680938-2017-10037
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
Report Date 02/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number391.965
Device LOT NumberA70A45
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/11/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/08/2017 Patient Sequence Number: 1
Treatment
ONE UNKNOWN PLATE, QUANTITY 1
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