MAUDE Adverse Event Report: TELEFLEX MEDICAL DEKLENE II POLYPROPELENE NON-ABSORBABLE SUTURE; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000861
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: needle breakage during a suture with capio brand 0 blue monofilament polypropylene threads.A new thread was then used, and it got dislodged.The incident took place on (b)(6) 2022, in the or, causing a suture to be undone, to be resumed and thus to extend the intervention time.No clinical signs or symptoms; condition reported as fine.
Additional Manufacturer Narrative
(b)(4).A visual functional dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of batch number 74h1902897 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to our specifications.No additional documents were reviewed as part of this complaint investigation.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.If the sample becomes available this investigation will be updated with the evaluation results.

• Brand Name: DEKLENE II POLYPROPELENE NON-ABSORBABLE SUTURE
• 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: 15958831
• Report Number: 3004365956-2022-00101
• Device Sequence Number: 4912992
• Product Code: GAW
• UDI-Device Identifier: 34026704603894
• UDI-Public: 14026704603890
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2022

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: 08/26/2024
• Device Model Number: IPN000861
• Device Catalogue Number: 833-124
• Device Lot Number: 74H1902897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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