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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
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 5/16/2023, it was reported by a facility representative via email that an instrument from an ar-2600sbs-9 speedbridge implant system broke inside the patient.This was discovered during a hip scope procedure on (b)(6) 2023.The broken piece remains in the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-3681 was received for investigation.No pictures of the reported event were provided.The device received for evaluation is not part of the reported ar-2600sbs-9.After further communication with the nurse from the outpatient surgery center, it was determined that ar-3681 was the faulty device.Functional testing was not performed due to the damage to the device.Visual inspection found deformation at the distal end at the instrument's tip, which was found to be bent and broken off.The most likely cause is attributable to misuse due to user error of using excessive force to pry and/or leverage the device.Refer to investigation photos.
Event or Problem Description
Additional information received on 10/6/2023: on 10/16/2023, an ar-3681 fibertak button was received with a broken tip for further investigation.After further communication with the nurse from the outpatient surgery center, it was determined that ar-3681 was the faulty device instead of the ar-2600sbs-9 speedbridge implant system.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17097197
• Report Number: 1220246-2023-06870
• Device Sequence Number: 20748929
• Product Code: MAI
• UDI-Device Identifier: 00888867319745
• UDI-Public: 00888867319745
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: SPEEDBRG IMP SYS W/BIO-COMP SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-9
• Device Lot Number: 15026279
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown