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	08/08/2018
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-op diagnosis :humerus patellar fracture procedure: fracture it was reported that the cable broke intra-operatively.Patient was involved in the event but no patient complications or symptoms occurred.
Additional Manufacturer Narrative
Product analysis: the cable has been returned in two sections.A visual review of the two severed ends indicates the two pieces do not match.As one end appears to be a clean cut and the other end appears to have been frayed.A microscopic review of the individual cables shows that the angles are similar and there does not appear to be necking that is associated with linear force.There is also damage to the eyelet noted.It appears the cable may have been cut.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: 7831744
• Report Number: 1030489-2018-01180
• Device Sequence Number: 1271711
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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: 10/18/2025
• Device Catalogue Number: 826-213
• Device Lot Number: 0603584W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR