MAUDE Adverse Event Report: ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number AR-13995N

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

We passed our suture tape sutures in horizontal mattress fashion.We were passing the fifth suture strand the tendon was quite thick.The suture passer had a difficult time passing through the tendon.We are able to pass the suture however noted that the tip of the suture passing needle had broken off upon retrieval.We obtained fluoroscopic imaging to assess the location of the needle tip.This was found to be within the rotator cuff tendon itself.We took multiple fluoroscopic images pulled traction on the previously placed sutures and noted the needle tip to move with traction within the rotator cuff tendon with excursion.The needle tip was nonvisible arthroscopically.We did however confirm its location within the rotator cuff tendon.At this time we elected to forego retrieval of the needle tip so as to preserve the quality of the rotator cuff tendon overall to facilitate healing.  we obtained a new suture passer as well as new needle for suture passing.We then completed passing her horizontal mattress sutures.We had 8 limbs of suture in total.These were placed evenly along the torn edge of the rotator cuff tendon to allow for a tension band repair construct.The sutures were shuttled out the anterolateral cannula.They were loaded to a swivel lock anchor.Pilot hole was created at the lateral aspect of greater tuberosity.The anchor was advanced.The sutures were tensioned appropriately.This reduced the rotator cuff tear nicely back down to the greater tuberosity footprint.The anchor was finally advanced with excellent fixation.The suture limbs were cut.We had secure repair of the entire tendon defect which was confirmed with gentle shoulder rotational movement under direct visualization of the repair.Fluoroscopic images were again obtained after final fixation to confirm the location of the needle tip.Again this was noted to be embedded within the rotator cuff tendon.  the subacromial space was lavaged of all bony debris.The shoulder was drained.The scope was removed and the portals were closed with interrupted 3-0 nylon sutures.We then turned our attention to open subpectoral biceps tenodesis.

• Brand Name: SCORPION-MULTIFIRE NEEDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 16466732
• MDR Text Key: 310516840
• Report Number: 16466732
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: (01)00888867015951
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AR-13995N
• Device Catalogue Number: AR-13995N
• Device Lot Number: 15008738
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male