LINEAR STRAIGHT BROACH HANDLE 803-03-159 510397

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-05 for LINEAR STRAIGHT BROACH HANDLE 803-03-159 510397 manufactured by Greatbatch Medical.

Event Text Entries

[76746245] The complaint sample was not returned to greatbatch for evaluation. Thus, an inspection could not be performed by greatbatch to confirm the reported event. A manufacturing review was completed. The reported lot number for this complaint is part of a field action recall, z-2055-2017. (b)(6). Recall number z-2055-2017 per fda website. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[76746246] It was reported during an unknown patient procedure that the pin that hold the lever in place fell out while working on the patient. An emergency x-ray was done to ensure that the pins did not fall inside of the patient. Pins were not found in the patient and one was recovered but the other pin was not found. The rep was not sure that the other pin was there to begin with. There was a ten (10) minute surgical delay. The procedure was completed successfully and no adverse events were reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004976965-2017-00066
MDR Report Key6610977
Report SourceDISTRIBUTOR
Date Received2017-06-05
Date of Report2017-05-12
Date of Event2016-11-07
Date Mfgr Received2017-05-12
Device Manufacturer Date2015-07-02
Date Added to Maude2017-06-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TONY SINGH
Manufacturer Street4545 KROEMER ROAD
Manufacturer CityFORT WAYNE IN 46818
Manufacturer CountryUS
Manufacturer Postal46818
Manufacturer Phone2607557466
Manufacturer G1GREATBATCH MEDICAL
Manufacturer Street4545 KROEMER ROAD
Manufacturer CityFORT WAYNE IN 46818
Manufacturer CountryUS
Manufacturer Postal Code46818
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLINEAR STRAIGHT BROACH HANDLE
Generic NameBROACH HANDLE
Product CodeHTR
Date Received2017-06-05
Model Number803-03-159
Catalog Number510397
Lot Number2988946
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGREATBATCH MEDICAL
Manufacturer Address4545 KROEMER ROAD FORT WAYNE IN 46818 US 46818


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-05

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