MAUDE Adverse Event Report: TELEFLEX MEDICAL MDK VI MF 0 TC43/HR26 48"; SUTURE, SURGICAL, ABSORBABLE,

Model Number	IPN000864
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).A visual, functional, or dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No additional tests were performed as part of this investigation since product code 833-137 is not currently in production.No issues or discrepancies were found in the device history record of product code 833-137/batch 74e2000730 that can be related to the failure mode reported.An nc was issued for another condition that is not related to the failure mode reported.A corrective action cannot be implemented at the time since the sample involved in the customer complaint was not sent for analysis.The 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.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Dart detached from capio suture and dart potentially broke as well.Occurred in (b)(6).

• Brand Name: MDK VI MF 0 TC43/HR26 48"
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE,
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12359598
• Report Number: 3004365956-2021-00269
• Device Sequence Number: 3936793
• Product Code: NEW
• UDI-Device Identifier: 14026704603920
• UDI-Public: 14026704603920
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K030212
• 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
• Report Date (Section B): 08/11/2021

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: 05/10/2023
• Device Model Number: IPN000864
• Device Catalogue Number: 833-137
• Device Lot Number: 74E2000730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1