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

Model Number	SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/10/2022, it was reported by an arthrex employee via phone that a punch from an ar-2600sbs-9 speedbridge implant system, is getting stuck in the patient bone and surgeon is having difficulty removing it.After malleating the punch into the bone, at the time of removal the handle starts spinning, as if it disengages from the shaft, and surgeon cannot grasp it.With the use of pliers, the punch is able to be removed and a reusable punch is used to complete the case.This was discovered during an rcr procedure on (b)(6) 2022.
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 device was not received for evaluation.Based off the information provided, the most likely cause of the reported failure is use error.

• Brand Name: SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
• 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: 19459482
• Report Number: 1220246-2024-04840
• Device Sequence Number: 6661911
• Product Code: MAI
• UDI-Device Identifier: 00888867319745
• UDI-Public: 00888867319745
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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 Expiration Date: 05/31/2026
• Device Model Number: SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-9
• Device Lot Number: 14976320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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