MAUDE Adverse Event Report: TELEFLEX MEDICAL FFB BL CO-BR 2 HC-5 1N 38" STRYKER; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000852
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No issues or discrepancies were found in the device history record of product code 3910-900-020 / batch 74e2202667 that can be related to the failure mode reported.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility is not being manufactured at the time.If the sample becomes available this investigation will be updated with the evaluation results.
Event or Problem Description
Reported issue: suture burst with traction causing problem in surgery.Additional information: the distributor stated that the procedure was delayed and ultimately the patient's pathology could not be completely resolved.A reconstruction of the anterior cruciate ligament and suture of the meniscal root was being performed by arthroscopy.The delay was because an attempt was made to seek authorization from the health authority to use the material of another manufacturer.The patient was under spinal anesthesia throughout the entire procedure.No injury reported.

• Brand Name: FFB BL CO-BR 2 HC-5 1N 38" STRYKER
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16569442
• Report Number: 3004365956-2023-00017
• Device Sequence Number: 6099840
• Product Code: GAT
• UDI-Device Identifier: 04026704603398
• UDI-Public: 04026704603398
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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: IPN000852
• Device Catalogue Number: 3910-900-020
• Device Lot Number: 74E2202667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown