MAUDE Adverse Event Report: TELEFLEX MEDICAL TEV GN BR 0 TC-43/HR26 2N 36"; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000859
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
During sacrospinous fixation after triggering the capio and when the doctor dragged the suture the suture tore suddenly.
Additional Manufacturer Narrative
Qn#(b)(4).No issues or discrepancies were found in the device history record of product code 833-114 / batch 74c1902282 that can be related to the failure mode reported.Refer to attach.A corrective action cannot be implemented at the time since the sample involved in the customer complaint was not sent for analysis.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
During sacrospinous fixation after triggering the capio and when the doctor dragged the suture the suture tore suddenly.

• Brand Name: TEV GN BR 0 TC-43/HR26 2N 36"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12213577
• Report Number: 3004365956-2021-00248
• Device Sequence Number: 19635804
• Product Code: GAT
• UDI-Device Identifier: 14026704603876
• UDI-Public: 14026704603876
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K021019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 03/20/2024
• Device Model Number: IPN000859
• Device Catalogue Number: 833-114
• Device Lot Number: 74C1902282
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1