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

Model Number	89-6109
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, the d-flex triangular retractor "broke" and came into contact with the patient.The piece of the device was immediately retrieved, and the procedure was completed successfully.An x-ray was taken of the patient and user facility personnel confirmed no instrument pieces were present.No report of injury.
Additional Manufacturer Narrative
V.Mueller has requested the device subject of the reported event be returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The d-flex triangular retractor subject of the reported event was returned for evaluation.Evaluation results indicated that the device was approximately 5 years old at the time of the event.It was determined that multiple components of the device had be repaired/replaced by a third-party service provider.Evaluation results also found that there was fraying of strands within the braided cable.The instructions for use states (page 5), "repair service regardless of age, all snowden-pencer device repairs must be returned to, and performed by, an authorized bd repair service center.Repairs performed by an unauthorized repair service center will immediately void any product warranty, and bd will no longer be able to ensure the safety of such repaired devices.Repairs for devices under warranty will be free of charge if performed at an authorized bd repair service center upon written request." the device history record (dhr) was reviewed, and no abnormalities were noted.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: 18858081
• Report Number: 1923569-2024-01003
• Device Sequence Number: 11591649
• Product Code: GCJ
• UDI-Device Identifier: 10885403122804
• UDI-Public: 10885403122804
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 89-6109
• Device Catalogue Number: 89-6109
• Device Lot Number: F19
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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