MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLAS CABLE SYSTEM; WIRE, SURGICAL

Catalog Number	826-211
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual review confirms cable breakage.Microscopic examination of the cable identified material deformation noted just below the location of fracture; the less damaged individual cable strand fracture surfaces reveal a fairly flat appearance and fracture plane angulation consistent with shear overload.This is consistent with shear overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with l3-iliac "ads"; and underwent fixation at l3-l4-l5-s1 using transforaminal lumbar interbody fusion.Intra-op, during wiring at l3, the wire disconnected.The surgeon passed the cable through the bone, placed the rod.After performing correction, the surgeon finished applying tension to the reported product and swaging with a cable crimper, but the cable disconnected.The tensioner was laid before swaging, and then swaging was performed.It was said that the tension itself should have been within 30 pounds.No fragment of the cable is remaining in the patient.There were no patient complications as a result of the alleged event.

• Brand Name: ATLAS CABLE SYSTEM
• Common Device Name: WIRE, SURGICAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 9849556
• Report Number: 1030489-2020-00330
• Device Sequence Number: 2929447
• Product Code: LRN
• UDI-Device Identifier: 00673978047966
• UDI-Public: 00673978047966
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/18/2020

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 Expiration Date: 07/09/2023
• Device Catalogue Number: 826-211
• Device Lot Number: 0398419W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1