MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLAS CABLE SYSTEM

Catalog Number	826-213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: neck 3,4 centrum old fracture luxation, left joint was interlocking incompetence and neurological damage procedure:cable fixation it was reported that intra-op, the cable broke.The product came in contact with the patient.No fragments of the cable were remaining in the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Product analysis result: visual microscopic there is a bend noted near the point of failure.The wire appears to have been twisted near the point of failure.Under microscopic review, there is necking noted at the ends of the strands.This necking is consistent with tensile overload from a pulling force.If information is provided in the future, a supplemental report will be issued.
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: 7279627
• Report Number: 1030489-2018-00247
• Device Sequence Number: 19305430
• Product Code: LRN
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 06/29/2024
• Device Catalogue Number: 826-213
• Device Lot Number: 0496001W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 02/27/2018; 06/14/2018; 08/08/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 03/09/2018; 07/13/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR