MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder surgery the punch (ar-1927pbs) of the speedbridge implant system was loose inside the handle.Therefore it was not possible to remove bone as usual.There was no harm for patient, operator or third party.The surgery was finished successfully and the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint is not confirmed.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: SPEEDBRG IMPL SYS W/BIO-COMPR SWVLK SP
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18419685
• Report Number: 1220246-2023-09777
• Device Sequence Number: 7846775
• Product Code: MAI
• UDI-Device Identifier: 00888867027329
• UDI-Public: 00888867027329
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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 IMPL SYS W/BIO-COMPR SWVLK SP
• Device Catalogue Number: AR-2600SBS-5
• Device Lot Number: 15138256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown