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

Model Number	IPN056766
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.
Event or Problem Description
Tapercut came off the suture during placement in sacrospinous ligament.No clinical signs, symptoms or conditions.
Additional Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.A dimensional inspection of the product involved in the complaint could not be conducted since the product returned.A functional inspection of the product involved in the complaint could not be conducted since the product was not returned.No issues or discrepancies were found in the device history record of product code 833-234 / batch 74c2101915 that can be related to the failure mode reported.A corrective action cannot be implemented at the time since the sample involved in the customer complaint was not sent for analysis.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 is not being manufactured at the time.If the sample becomes available this investigation will be updated with the evaluation results.
Additional Manufacturer Narrative
Qn#(b)(4).During the visual inspection it was detected that the suture is broke in two parts, one of them have a length of 24 inch and the other one have a length of 24 inch with 1 bullet attached at the end.The needle show signs of contamination and the suture have damage through the body.During the dimensional inspection it was detected that the suture is broke in two parts, one of them have a length of 24 inch and the other one have a length of 24 inch.Per operational hazards - incorrect or inappropriate output or functionality - sutures are intended to be used by surgeons qualified in the appropriate indication/procedures / suturing device ifu.The suture is not designed for use/compatibility with other medical devices.All suture material ifu's contain a caution statement for device handling.In summary, based on the findings during visual and dimensional inspection, customer complaint cannot be confirmed due to the condition of the sample to perform a proper investigation and determine a root cause.No issues or discrepancies were found in the production device history record (dhr) of this product.Manufacturing personnel will be notified of this event for awareness.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14686298
• Report Number: 3004365956-2022-00041
• Device Sequence Number: 5538371
• Product Code: GAW
• UDI-Device Identifier: 14026704735317
• UDI-Public: 14026704735317
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K193530
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2022

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: 03/22/2026
• Device Model Number: IPN056766
• Device Catalogue Number: 833-234
• Device Lot Number: 74C2101915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 07/05/2022; 09/23/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/08/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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