MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43 2N 48; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000860
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: the surgeon loaded the polypropylene suture into capio slim device correctly and all engaged correctly.He said that as he depressed the capio slim plunger while on the sacrospinous ligament and retracted it, the suture was broken at the capio head, and the dart end had snapped off the suture and was still in the carriage of the capio.He was able to remove the dart from the capio carriage/head and use another polypropylene suture to complete the case successfully.This time the suture was fine.
Additional Manufacturer Narrative
(b)(4).The device history review could not be conducted since the lot number was not provided.Teleflex will continue to monitor and trend related events.

• Brand Name: DEK BL MF 0 TC-43 2N 48
• 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: 16373205
• Report Number: 3004365956-2023-00015
• Device Sequence Number: 15142994
• Product Code: GAW
• UDI-Device Identifier: 14026704603883
• UDI-Public: 14026704603883
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K930738
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

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: IPN000860
• Device Catalogue Number: 833-123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.
• Patient Sex: Unknown