MAUDE Adverse Event Report: TELEFLEX MEDICAL POL GN BR 4-0 ME-2 2N 18"; SUTURE, NONABSORBABLE, SYNTHET

Model Number	IPN914473
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).No issues or discrepancies were found in the device history record of product code 6-692 / batch 74d2001662 that can be related to the failure mode reported.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Today a surgeon was operating with a 4-0 polydek suture ref 6-692, lot 74d2001662 and the needle broke off the suture and fell into the orbit.Luckily the surgeon was able to retrieve the needle and no harm came to the patient.However, this is the second incident we have had of this kind.
Event or Problem Description
Today a surgeon was operating with a 4-0 polydek suture ref (b)(4), lot 74d2001662 and the needle broke off the suture and fell into the orbit.Luckily the surgeon was able to retrieve the needle and no harm came to the patient.However, this is the second incident we have had of this kind.
Additional Manufacturer Narrative
Qn# (b)(4).1 sample of product code 6-692 was received on a ziploc bag with a disinfection tag and with carrier.Only a portion of the suture was received without needle attached in both sides.The sutures shows signs of manipulation and contamination was detected throughout the needle.The suture was dimensionally inspected, suture specification is 18" long however during the dimensional inspection, the suture was found to be 8" 3/8 long.No functional inspections were performed as part of this investigation due are not related with the complaint notification.Incoming inspection records of the needle lot involved in the manufacturing of product code 6-692 / batch 74d2001662 were reviewed, no issues or discrepancies were found.Based on the findings during visual and dimensional inspection, customer complaint cannot be confirmed.No issues or discrepancies were found in the production and incoming inspection records that can be related to the failure mode reported.Based on the findings during visual and dimensional inspection, customer complaint cannot be confirmed.No issues or discrepancies were found in the production and incoming inspection records that can be related to the failure mode reported.

• Brand Name: POL GN BR 4-0 ME-2 2N 18"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHET
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11820642
• Report Number: 3004365956-2021-00181
• Device Sequence Number: 3149203
• Product Code: GAT
• UDI-Device Identifier: 14026704716293
• UDI-Public: 14026704716293
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 03/15/2025
• Device Model Number: IPN914473
• Device Catalogue Number: 6-692
• Device Lot Number: 74D2001662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1