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	11/04/2019
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
It was reported that the patient underwent a surgery for fracture.Cable was being used for tying the patella.Intra-op, the cable broke.No fragment of the broken instrument remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical review confirmed that the cable has been broken into two strands.Microscopic examination of the cable revealed multiple bends in the cable with strand damage right above and below the breakage.The angle and location of strand breakage is consistent with the cable coming in contact with a sharp corner during tensile loading.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: 9392656
• Report Number: 1030489-2019-01358
• Device Sequence Number: 4202376
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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 Catalogue Number: 826-213
• Device Lot Number: 0710860W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/01/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR