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

Model Number	SPEEDBRG IMP SYS W/BIO-COMP SWVLK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via phone that an ar-2600sbs-4 speedbridge¿ implant system with biocomposite swivelock¿ had an issue.During a rotator cuff repair on (b)(6) 2022, the surgeon was trying to implant the device, the anchor body was not sitting correctly inside the bone yet and had not been implanted fully when part of the anchor broke inside the patient.Two-thirds of the anchor was left inside the patient's bone and the surgeon deemed it to be affixed securely and seated correctly, and the other fragment was removed from the patient.The case was then completed successfully with no impact to the patient.

• Brand Name: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15534505
• Report Number: 1220246-2022-05565
• Device Sequence Number: 7887904
• Product Code: MAI
• UDI-Device Identifier: 00888867027312
• UDI-Public: 00888867027312
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• Device Catalogue Number: AR-2600SBS-4
• Device Lot Number: 14971628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/03/2022
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown