MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION LOOK; LOOK¿ NYLON, 4-0, BLACK, 18", C17

Model Number	921B
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for the reported finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, in-process or final inspection process.The actual device was discarded by the end user.No sterile devices from the finished good lot were returned for analysis.A retained sample from the device history record was available, visually reviewed and tested.No visual defects or abnormalities were observed.The device met all specifications including the usp tensile strength and bend/ductility requirements.The suture breaking during use most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength.It's also possible the devices are being gripped on or near the swaged end of the needle, damaging the suture, allowing the suture to break free from the needle component.The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps, surgical instrument on or near the swaged area or near the tip of the device, when excessive force is applied, when the device(s) are used in applications involving tortuous tissue or with a needle tip design that may not be appropriate for the specific tissue or procedure.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 receiving photos or the actual device for review or receiving additional details regarding the preoperative preparation of the device, tools utilized to grasp the needle device, procedure performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
Customer used sutures for tenotomy surgery and had two complications with them.First they kept ripping and second, the needle broke off in the patient.The patient had to be sent for xrays to confirm and patient had to go to an orthopedic surgeon to have it removed.The needle was removed without injury or complications.

• Brand Name: LOOK
• Common Device Name: LOOK¿ NYLON, 4-0, BLACK, 18", C17
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 12301288
• Report Number: 3010692967-2021-00029
• Device Sequence Number: 17074368
• Product Code: GAB
• UDI-Device Identifier: 10848782009708
• UDI-Public: (01)10848782009708(17)260107(10)AAHF342
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K903029
• 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): 08/10/2021
• Report Date (Section F): 07/14/2021

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: 01/07/2026
• Device Model Number: 921B
• Device Lot Number: AAHF342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2021
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention