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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an ar-2600sbs-8 speed-bridge implant system had an issue with the scorpion needle within the kit breaking.The needle broke off inside the patient during a rotatory cuff resection procedure.No harm came to the patient and the metal piece was retrieved.A new scorpion was opened and used in place of the broken item to complete the procedure without further issue.
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.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14744706
• Report Number: 1220246-2022-05120
• Device Sequence Number: 4677609
• Product Code: MAI
• UDI-Device Identifier: 00888867319738
• UDI-Public: 00888867319738
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/20/2022

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 Model Number: SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-8
• Device Lot Number: 14918539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown