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

Model Number 921B

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/28/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 12301288
• MDR Text Key: 267522966
• Report Number: 3010692967-2021-00029
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K903029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2021,08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 921B
• Device Lot Number: AAHF342
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• 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
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/10/2021 Patient Sequence Number: 1