MAUDE Adverse Event Report: SURGICAL SPECIALTIES LOOK NYLON REV CUTTER; NYLON, 2-0, BLACK, 18" 3/8 CIR RC

Model Number	927B
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The suture broke away from the thread while dr.(b)(6) was suturing.He lost the suture in the patient and had to go digging for it.He got it out but wants to switch back to the brand he was using previously.All of our doctors are fairly skilled suturing, dr.(b)(6) is probably by far the most experienced with probably 30 years of experience and this was not user error.We unfortunately have also had issue with the sharpoint brand.Mostly breakage of the thread when they are tying off.
Additional Manufacturer Narrative
A review of the device history records for the finished good lot and the raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.No additional complaints have been reported for this lot.No samples or photographs of the defective device were returned for evaluation.If samples become available at a later time, the devices will be reviewed and tested and the results will be included in the file.A follow-up report will be submitted to you at that time.The suture breaking free from the needle or detaching from the needle during use most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength/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 material, allowing the suture to break free from the needle device.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.The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand.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 failed devices, magnified photos of the failed devices, receiving sterile samples from the same finished good lot to review/test or receiving details regarding the method utilized to remove the devices from the packages, preoperative preparation of the device(s), tools utilized to grasp the devices, procedures performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• Brand Name: LOOK NYLON REV CUTTER
• Common Device Name: NYLON, 2-0, BLACK, 18" 3/8 CIR RC
• Manufacturer (Section D): SURGICAL SPECIALTIES; corredor tijuana rosarito 2000; #24702 b, ejido franciso villa; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 1100 berkshire blvd.; ste 308; reading PA 19608
• Manufacturer Contact: kelly knappenberger ; corredor tijuana-rosarito 2000 #24702b; #24702 b, ejido franciso villa; tijuana baja california 22235 ; MX 22235
• MDR Report Key: 16527317
• Report Number: 3010692967-2023-00011
• Device Sequence Number: 16799724
• Product Code: GAR
• UDI-Device Identifier: 10848782009746
• UDI-Public: (01)10848782009746(17)250331(10)AAFV837
• Combination Product (Y/N): N
• PMA/510(K) Number: K903029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2023
• Report Date (Section F): 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 927B
• Device Catalogue Number: 927B
• Device Lot Number: AAFV837
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2023
• Device Age: 36 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown