MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43 2N 48" BSC; DEKLENE MAXX POLYPROPELENE NON

Catalog Number	833-234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the thread breaks during fixation.The thread was replaced with a new one, but the same reproducibility occurs.The procedure was completed without any problems using another lot".No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the thread breaks during fixation.The thread was replaced with a new one, but the same reproducibility occurs.The procedure was completed without any problems using another lot".No patient harm or injury.
Additional Manufacturer Narrative
Qn # (b)(4).One sample of catalog was received for evaluation.Sample wasn't received in its original packaging.Sample was visually inspected and it was noticed that the suture showed signs of manipulation (bent suture) additionally it did not have the second needle corresponding to the product, the suture was shorter in length.This product code uses a deklene suture that is provided by coventry facility.With the information available at this time this customer complaint cannot be confirmed as a nuevo laredo manufacturing related as there is not enough evidence that shows that the damage observed on sample was directly related to the manufacturing process since damage could have occurred during procedure of loading and usage process of the device.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.The suture used on this product is manufactured at sister facility teleflex coventry, therefore notification will be sent to the site for further evaluation.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: DEK BL MF 0 TC-43 2N 48" BSC
• Common Device Name: DEKLENE MAXX POLYPROPELENE NON
• 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: 18942254
• Report Number: 3004365956-2024-00032
• Device Sequence Number: 20899245
• Product Code: GAW
• UDI-Device Identifier: 14026704735317
• UDI-Public: 14026704735317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: 833-234
• Device Lot Number: 74F2200931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown