MAUDE Adverse Event Report: TELEFLEX MEDICAL FFB WH BR 2 HC-5 1N 38" 1 PER BX BIOMET; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000885
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the needle detached from suture thread.The surgeon sutured the transplant using maxbraid.At the end of the suture, the surgeon pulled the maxbraid from the needle on his needle holder and the needle detached itself from the maxbraid." no patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that "the needle detached from suture thread.The surgeon sutured the transplant using maxbraid.At the end of the suture, the surgeon pulled the maxbraid from the needle on his needle holder and the needle detached itself from the maxbraid." no patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4), the sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports that a visual exam was performed , and it was observed that the needle body showed signs of damage.A device history record review was performed , and no relevant findings were identified.The manufacturing site also reports that functional testing could not be performed due to the condition of the returned sample.The complaint could not be confirmed.

• Brand Name: FFB WH BR 2 HC-5 1N 38" 1 PER BX BIOMET
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17360846
• Report Number: 3004365956-2023-00053
• Device Sequence Number: 5290012
• Product Code: GAT
• UDI-Device Identifier: 54026704601696
• UDI-Public: 54026704601696
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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 Model Number: IPN000885
• Device Catalogue Number: 900338
• Device Lot Number: 74H2201661
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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: Male