MAUDE Adverse Event Report: TELEFLEX MEDICAL TEV WH BR 5 KAC-25 1N 24" NICELOOP; SUTURE, NONABSORBABLE, SYNTHE

Catalog Number	SMSL50203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "two nice loops broke in the same case.From the information provided upon the reporter's initial complaint.It happened during surgery, there was no impact to patient, no medical intervention, and no surgical delay".
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "two nice loops broke in the same case.From the information provided upon the reporter's initial complaint.It happened during surgery, there was no impact to patient, no medical intervention, and no surgical delay".
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed based only on the information and picture provided; to perform a proper evaluation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.The device history record 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.Dhr shows that the product was assembled & inspected according to our specifications.The dhr records shows that the tension tests met the specifications above the individual minimum expected of 2 lbs, the average of the results obtained was 14.72 lbs.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available.If the sample becomes available this investigation will be updated with the evaluation results.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: TEV WH BR 5 KAC-25 1N 24" NICELOOP
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20968955
• Report Number: 3004365956-2024-00093
• Device Sequence Number: 19863925
• Product Code: GAT
• UDI-Device Identifier: 14026704608727
• UDI-Public: (01)14026704608727(11)230510(17)280510(10)74E2300995(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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 Catalogue Number: SMSL50203
• Device Lot Number: 74E2300995
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown