MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLAS CABLE SYSTEM

Catalog Number	826-213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on 22 nov 2016, the patient got the surgery due to fracture of hip joint prosthesis.Intra-op, it was found that the product broke two times in normal torque range.The physician had to replace a new one to complete the surgery successfully.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual review confirms cable breakage.Microscopic examination of the cable identifies multiple bends in the cable with strand damage away from the fracture area.All strand fracture surfaces appear to contain varying degrees of damage and/or mechanical smearing.Microscopic examination of multiple individual cable strand fracture surfaces reveal fairly flat fracture surfaces, with a surface angulation consistent with shear overload.Additionally, several other strands appear to show necking, consistent with tensile overload.This suggests initial failure due to shear, thus weakening the cable, placing increasing tensile stress on the remaining intact strands until ultimate tensile failure.The above observations suggests initial failure due to shear, thus weakening the cable, placing increasing tensile stress on the remaining intact strands until ultimate tensile failure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATLAS CABLE SYSTEM
• Common Device Name: CABLE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6232244
• Report Number: 1030489-2017-00066
• Device Sequence Number: 11027038
• Product Code: ISN
• UDI-Device Identifier: 00673978047980
• UDI-Public: 00673978047980
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2024
• Device Catalogue Number: 826-213
• Device Lot Number: 0456161W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided; 03/06/2017
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 03/31/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR