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

Model Number	IPN000864
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual, dimensional, or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history review could not be conducted since the lot number of the reported product code was not provided.No corrective action can be implemented due to the lack of batch number to perform a proper investigation to determine a root cause.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 nor is 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
Physician says that when he fired the suture to deploy through the ligament, the bullet on the end of the suture gets stuck.He attempted a second time and the device misfired.Last attempt the bullet came off suture.Physician opened a new capio slim and completed the procedure with no issues.
Additional Manufacturer Narrative
(b)(4).No issues or discrepancies were found in the device history record of product code 833-137 / batch 74c2201024 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 nor is being manufactured at the time.If the sample becomes available this investigation will be updated with the evaluation results.
Event or Problem Description
Physician says that when he fired the suture to deploy through the ligament, the bullet on the end of the suture gets stuck.He attempted a second time and the device misfired.Last attempt the bullet came off suture.Physician opened a new capio slim and completed the procedure with no issues.

• Brand Name: MDK VI MF 0 TC43/HR26 48"
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE,
• 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: 15494966
• Report Number: 3004365956-2022-00070
• Device Sequence Number: 12072838
• Product Code: NEW
• UDI-Device Identifier: 14026704603920
• UDI-Public: 14026704603920
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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: 03/09/2025
• Device Model Number: IPN000864
• Device Catalogue Number: 833-137
• Device Lot Number: 74C2201024
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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
• Patient Sex: Unknown