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	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Cure of prolapse on (b)(6) 2019.When using capio sutures, 2 harpoons (attached to the sacrospinous ligament through forceps) dislodged from the wire during the 1st and 3rd passages.Presence of 2 free harpoons in the sacrospinous ligament not linked to a wire: risk of migration that can have potentially serious clinical consequences for the patient.Need to change the medical device in order to continue the procedure.Extension of the procedure length.Device 3 of 3.Event date: (b)(6) 2019.
Additional Manufacturer Narrative
Qn#(b)(4).A dhr review could not be conducted since the lot number of product code was not provided.A corrective action cannot be implemented at the time since the sample involved in the customer complaint was not sent for analysis.No documentation can be reviewed due to the lack of the batch number to perform a proper investigation.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
Cure of prolapse on (b)(6) 2019.When using capio sutures, 2 harpoons (attached to the sacrospinous ligament through forceps) dislodged from the wire during the 1st and 3rd passages.Presence of 2 free harpoons in the sacrospinous ligament not linked to a wire: risk of migration that can have potentially serious clinical consequences for the patient.Need to change the medical device in order to continue the procedure.Extension of the procedure length.Device 3 of 3.Event date: (b)(6) 2019.

• Brand Name: TEV GN BR 0 TC-43/HR26 2N 36"
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12632358
• Report Number: 3004365956-2021-00298
• Device Sequence Number: 4344819
• Product Code: GAT
• UDI-Device Identifier: 14026704603876
• UDI-Public: 14026704603876
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/12/2021

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 Model Number: IPN000859
• Device Catalogue Number: 833-114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown