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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SALZBURG BENDING PLIERS-SMOOTH JAWS FORMINI PLATES PLIERS, SURGICAL

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SYNTHES SALZBURG BENDING PLIERS-SMOOTH JAWS FORMINI PLATES PLIERS, SURGICAL Back to Search Results
Catalog Number 329.12
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. There was no reported patient involvement associated with the complained event. Date of event: unknown. Device is an instrument and is not implanted/explanted. The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received. The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history record review was performed for the subject device lot. Manufacturer: synthes (b)(4). Date of manufacture: apr 14, 2008. The review 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 on (b)(6) 2017 that the hospital¿s technician from central serial processing department had two (2) broken instruments that came down from the operating room. The bending pliers were broken into two pieces at the instrument hinge and the depth gauge is reported as broken at the distal tip. No additional information was given from the hospital, and nothing else is forthcoming. There was no reported patient involvement associated with the reported event; however, it is unknown when the reported device were broken. The reported issues were discovered during instrument inspection. This report is 1 of 2 for (b)(4).

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. The subject device has been received by the manufacturer and is undergoing investigation. The results of the investigation are pending completion and will be submitted in a supplemental report. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

A product development investigation was performed for the subject devices. This complaint is confirmed for the returned 329. 12 pliers. The returned pliers are broken as reported. A portion of the hinge pin/screw has sheared off and is missing from the device and therefore the device is now in two pieces. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned pliers are already broken. This complaint is not confirmed for the returned 319. 04 depth gauge. The tip of the measuring hook on the returned depth gauge is bent, but not broken as reported. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already bent. No new malfunctions were identified as a result of the investigation. A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, and drawing review were performed as part of this investigation. Part# 329. 12 bending pliers-smooth jaws for mini plates: the returned pliers are broken as reported. A portion of the hinge pin/screw has sheared off and is missing from the device and therefore the device is now in two pieces. The diameter of the hinge pin/screw that sheared in half could not be measured at cq as one portion is missing and one portion is inaccessible (still retained in one half of the pliers). Drawing was reviewed during this investigation. No product design issues or discrepancies were observed. The root cause is most likely due to application of excessive force which exceeded the shear strength of the hinge pin/screw. Part# 319. 04 depth gauge for 2. 7mm & small screws: the tip of the measuring hook on the returned depth gauge is bent, but not broken as reported. The height of the distal hook measured 1. 79mm (calipers) at cq which is within specification of 1. 70mm-1. 80mm per measuring hook component drawing. Depth gauge assembly drawing and hook component drawing were reviewed during this investigation. No product design issues or discrepancies were observed. The bent condition of the measuring hook tip most likely is due to rough handling. 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.

 
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Brand NameBENDING PLIERS-SMOOTH JAWS FORMINI PLATES
Type of DevicePLIERS, SURGICAL
Manufacturer (Section D)
SYNTHES SALZBURG
karolingerstrasse
salzburg 5020
AU 5020
Manufacturer (Section G)
SYNTHES SALZBURG
karolingerstrasse
salzburg 5020
AU 5020
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6453625
MDR Text Key71738023
Report Number3009417901-2017-10009
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,Followup
Report Date 03/10/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number329.12
Device LOT Number5018220
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/04/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/14/2008
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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