MAUDE Adverse Event Report: CAREFUSION INC. SNOWDEN-PENCER DIAMOND-FLEX TRIANGULAR RETRACTOR

Model Number	89-6110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was returned for evaluation.Evaluation results are pending.A follow-up mdr will be submitted once evaluation results are available.
Event or Problem Description
The user facility reported that during a patient procedure that their snowden-pencer triangular retractor broke and fell into the patient's body.The detached components were successfully retrieved.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The device was returned to the supplier for evaluation.Upon further evaluation, it was found that part of the tension cable had separated from the device.The remaining tension cable was examined at the frayed end and found to be severed at various lengths, which would indicate that the cables severed at different points in time from wearing against the internal surfaces of the flex segment pieces.Discolored laser markings were also found which are consistent with several years of usage.The warranty section of the ifu states, "carefusion guarantees every surgical device bearing the snowden-pencer brand name to be free of functional defects in workmanship and materials when used normally for its intended surgical purpose.Any snowden-pencer device proving to be defective will be replaced or repaired at no charge.This device carries a lifetime warranty against manufacturer defects and a 1 year warranty against wear." the device was manufactured in 2016 and is more than seven years old.A review of the complaint log was performed, and no other complaints were identified with this batch.The dhr was also reviewed, and no issues were identified.Based on the fraying of the cable in various locations and the age of the device, the root cause of this event can likely be attributed to wear over time.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER DIAMOND-FLEX TRIANGULAR RETRACTOR
• Common Device Name: TRIANGULAR RETRACTOR
• Manufacturer (Section D): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer (Section G): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18857980
• Report Number: 1923569-2024-01002
• Device Sequence Number: 8239695
• Product Code: GCJ
• UDI-Device Identifier: 10885403122811
• UDI-Public: 10885403122811
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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 Model Number: 89-6110
• Device Catalogue Number: 89-6110
• Device Lot Number: F16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown