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).
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.Patient is male.The surgeon is very experiences in sport medicine, that regularly does laminoplasty.No consequences for the patient.Patient fine.No delay due to this incident.No medical pre-existing conditions that would might have contributed to this incident.It happened at the end of the procedure, suture was completed, no device replaced." see associated mdr #3004365956-2023-00053.
Additional Manufacturer Narrative
(b)(4).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.A device history record review was performed, and no relevant findings were identified.If the sample becomes available this investigation will be updated with the evaluation results.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.Patient is male.The surgeon is very experiences in sport medicine, that regularly does laminoplasty.No consequences for the patient.Patient fine.No delay due to this incident.No medical pre-existing conditions that would might have contributed to this incident.It happened at the end of the procedure, suture was completed, no device replaced." see associated mdr #3004365956-2023-00053.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17551615
• Report Number: 3004365956-2023-00055
• Device Sequence Number: 17806825
• 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): 07/31/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: IPN000885
• Device Catalogue Number: 900338
• Device Lot Number: 74H2201661
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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