MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION MEXICO HU-FRIEDY; 6-0 BLUE POLYPROPYLENE 3/8 CIRCLE

Model Number	PSN8660P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two (2) lots reported aaft510, aafj671 (manufacture date 12/10/2019, expiration date 12/10/2024, udi code (b)(4) a review of the device history records for the reported finished good lot(s) and raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.Sterile samples from the reported lot(s) were returned by the end user for visual review and needle pull testing.No defects were observed on the suture, needles or the attachments.The devices met the current specifications including the needle pull requirements for a for a 6-0 ppn device.The needles detaching from the suture during use most likely resulted from the interaction of specific procedural related stress in contrast to the strength of the attachment.It's also possible the devices are being grasped on or near the swaged end of the needle, damaging the suture, allowing the suture to break free from the needle component.The ¿precautions¿ section in the ifu for the device states, ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point¿.Without reviewing the actual reported device(s), receiving magnified photos of the actual devices or receiving detailed information regarding the pre-operative preparation of the device(s), tools utilized to grasp the device, procedure performed or the surgeon's technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
The dr.Reported the devices were used for three (3) different patients/procedures.The needles detached from the suture during graft procedures.No injury reported.No intervention required.

• Brand Name: HU-FRIEDY
• Common Device Name: 6-0 BLUE POLYPROPYLENE 3/8 CIRCLE
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION MEXICO; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 11963308
• Report Number: 3010692967-2021-00019
• Device Sequence Number: 14699436
• Product Code: GAW
• UDI-Device Identifier: 10889950001896
• UDI-Public: (01)10889950001896(17)250228(10)AAFT510
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2021
• Report Date (Section F): 05/14/2021

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: 02/20/2025
• Device Model Number: PSN8660P
• Device Catalogue Number: PSN8660P
• Device Lot Number: AAFT510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/16/2021
• Device Age: 15 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/14/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1