MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported via fda medwatch letter (mw5094324) that the following incident occurred on (b)(6) 2020: distal port of the needle broke off during surgical case.The part number listed in the letter was ar-2600bs9.This is not a valid arthrex part number.A request has been sent to the facility incident reporter requesting confirmation of the part number and additional information.Additional information obtained 5/15/20: the procedure was a shoulder arthroscopy, rotator cuff repair.The part number is confirmed to be ar-2600sbs-9 (lot 10430732).An x-ray was taken and no foreign body was found however the facility reports they were unable to account for the needle tip.Staff believes the sales rep gave a new device to the surgeon to complete the procedure.The device is reported, by the facility, to have been taken by the sales rep who was present during the procedure.The lot number provided is not a valid match to the confirmed arthrex part number provided.Additional information obtained 5/18/20: the sales rep who was present has confirmed that he did not take the device from the facility, nor did he have a reason to as he states he had no knowledge of the device tip being broken.Device disposition is therefore unknown.

• Brand Name: SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10109071
• Report Number: 1220246-2020-01871
• Device Sequence Number: 3406669
• Product Code: MAI
• UDI-Device Identifier: 00888867319745
• UDI-Public: 00888867319745
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other