ATLAS CABLE SYSTEM 826-213

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-17 for ATLAS CABLE SYSTEM 826-213 manufactured by Warsaw Orthopedics.

Event Text Entries

[90419339] Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10


[90419340] It was reported that during surgery, the cable broke. The product came in contact with the patient. No fragments remained in the patient. No patient complications were reported as a result of the event.
Patient Sequence No: 1, Text Type: D, B5


[101042895] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[101042896] The patient underwent hip replacement surgery due to congenital hip dysplasia.
Patient Sequence No: 1, Text Type: D, B5


[115376503] Additional information: the product was returned with four distinctive failures in the cable. Under microscopic review three of the failures show necking at the ends of the individual strands and a tightening of the original cable twist. These observations are consistent with an overload from tension. The other failure appears to be the result of a cut. There is a uniformity to the angle of the single strands and witness marks can be seen on the face of the strands. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[124180144] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2017-02211
MDR Report Key6953929
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-10-17
Date of Report2018-10-04
Date of Event2017-09-22
Date Mfgr Received2018-08-08
Device Manufacturer Date2016-06-27
Date Added to Maude2017-10-17
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 ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1WARSAW ORTHOPEDICS
Manufacturer Street2500 SILVEUS CROSSING
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATLAS CABLE SYSTEM
Generic NameCABLE
Product CodeISN
Date Received2017-10-17
Returned To Mfg2018-06-18
Model NumberNA
Catalog Number826-213
Lot Number0495809W
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerWARSAW ORTHOPEDICS
Manufacturer Address2500 SILVEUS CROSSING WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-17

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