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

Model Number	SPEEDBRG IMP SYS W/BIO-COMP SWVLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is not confirmed, but external circumstances might have altered the original state of the device.One unpackaged c0795, disposable punch 4.5mm, unsterile, a component from product ar-2600sbs-4, was received for evaluation.The other components from the same product were not returned.Visual evaluation revealed deformation of the blue plastic handle.A deep imprint of a zip tie used for labeling could be found on the surface of the handle, indicating the plastic had been heated up to the point of becoming malleable.The shaft was fully attached to the handle and could not be rotated freely.A probable cause to the handle deformation can be attributed to the decontamination process before the device was received for evaluation, due to the presence of the labeling zip tie imprint.This also might have caused the shaft to re-adhere to the handle, limiting the assessment of the complaint allegation.
Event or Problem Description
It was reported that during a speedbridge rotator cuff repair surgery the shaft of the punch became loose such that manipulating the handle was not affecting the punch and the handle was just spinning on the metal shaft.Therefore the surgeon could not dislodge the punch from the prepared bone by twisting and backing it out instead he had to pull out directly.There was no harm for patient, operator or third party reported.The surgery was finished successfully with with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: SPEEDBRG IMP SYS W/BIO-COMP SWVLK
• 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: jared engle ; 8009337001
• MDR Report Key: 19310605
• Report Number: 1220246-2024-03234
• Device Sequence Number: 2972328
• Product Code: MAI
• UDI-Device Identifier: 00888867027312
• UDI-Public: 00888867027312
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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
• Device Catalogue Number: AR-2600SBS-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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