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

Model Number IPN000864

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2022

Event Type  malfunction  

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.A dhr 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.

Event Description

Physician says that when he fires 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"
• Type of Device: 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15321801
• MDR Text Key: 305260436
• Report Number: 3004365956-2022-00060
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 14026704603920
• UDI-Public: 14026704603920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000864
• Device Catalogue Number: 833-137
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1