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	Insufficient Information (4580)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
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, that during a rotator cuff repair procedure two of the lateral ar-2600sps-8 anchors broke.All pieces were removed.The case was completed using 2-single wrapped anchors.

• 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: 11435954
• Report Number: 1220246-2021-02675
• Device Sequence Number: 12054516
• Product Code: MAI
• UDI-Device Identifier: 00888867319738
• UDI-Public: 00888867319738
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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: 06/30/2021
• Device Model Number: SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-8
• Device Lot Number: 10438157
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1