MAUDE Adverse Event Report: TELEFLEX MEDICAL DEKLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000860
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.
Event or Problem Description
A capio loaded with a bullet was inserted into the patient by the surgeon.Upon withdrawing the instrument it was noted by the surgeon that the bullet tip was no longer attached to its suture thread.
Additional Manufacturer Narrative
(b)(4).Due to the age of the lot number (manufactured on 2016), the dhr is not available at the teleflex nuevo laredo site.A corrective action cannot be implemented 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.
Event or Problem Description
A capio loaded with a bullet was inserted into the patient by the surgeon.Upon withdrawing the instrument it was noted by the surgeon that the bullet tip was no longer attached to its suture thread.

• Brand Name: DEKLENE POLYPROPYLENE 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14116308
• Report Number: 3004365956-2022-00033
• Device Sequence Number: 19402446
• Product Code: GAW
• UDI-Device Identifier: 14026704603883
• UDI-Public: 14026704603883
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 09/01/2021
• Device Model Number: IPN000860
• Device Catalogue Number: 833-123
• Device Lot Number: 74H1603517
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• 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