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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF ROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL PLIERS, SURGICAL

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SYNTHES HAGENDORF ROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL PLIERS, SURGICAL Back to Search Results
Catalog Number 03.607.009
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2017
Event Type  Malfunction  
Manufacturer Narrative

Patient information is not available for reporting. Udi: (b)(4). Implant and explant dates: device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter's telephone: (b)(6). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported during an unknown surgical procedure on (b)(6)2017, the rod introduction pliers broke. All fragments were retrieved. Surgery was completed successfully with a delay of approximately one (1) hour. No patient harm was reported. Concomitant devices reported: wire (part number unknown, lot number unknown, quantity 1). This report is for one (1) rod introduction pliers for uss polyaxial. This is report 1 of 1 for (b)(4).

 
Manufacturer Narrative

Device history records review was completed for part# 3. 607. 009, lot# 8929293. Manufacturing location: (b)(4), manufacturing date: may 22, 2014. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Manufacturing evaluation was completed. The visual inspection shows that the device is in a used condition and visible damages and deformations were observed. The review of the production history revealed that this uss-ii polyaxial rod instruction pliers was manufactured in may 2014 per the specifications. No manufacturing related issue that would have contributed to this complaint were found. The device has been tested with the functional gages. During opening and closing unsmooth running was observed because of the damages and deformation of the plier. This damages and unsmooth running of the plier has no impact on important product functionality. No production failure has been found. This complaint is not confirmed. 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

Date received by manufacturer was inadvertently reported as aug 18, 2017 in mw-459601. The correct date is sep 12, 2017. 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 NameROD INTRODUCTION PLIERS FOR 6.0MM RODS FOR USS POLYAXIAL
Type of DevicePLIERS, SURGICAL
Manufacturer (Section D)
SYNTHES HAGENDORF
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer (Section G)
SYNTHES HAGENDORF
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6754919
MDR Text Key81609899
Report Number3003875359-2017-10374
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,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/04/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number03.607.009
Device LOT Number8929293
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/18/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/22/2014
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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