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	12/14/2018
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 3-4,4-5 intervertebral disc prolapse procedure: posterior cervical laminectomy and cable fixation it was reported that intra-op, product was broken.Patient achieved solid fusion.The product came in contact with the patient.No fragment remains in the patient.No patient symptoms or complication were reported as result of this event.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the cable has broke near the end of the connector.The welded end of the cable has also been bent and a portion of it has been broken off.Optical examination of the fracture surface revealed an angulated shear lip and a frayed end on the cable side.It appears the welded end was possibly cut with some cutters and the cable broke due to excessive force.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: 8224486
• Report Number: 1030489-2019-00014
• Device Sequence Number: 10813664
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 04/17/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1