MAUDE Adverse Event Report: ARTHREX, INC. FBRTK SPDBRG IMP SYS W/ BC SWVLK; FASTENER, FIXATION, NONDEGRADEABLE, SOFT TISSUE

Model Number	FBRTK SPDBRG IMP SYS W/ BC SWVLK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2024
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 (b)(6) 2024 it was reported by a sales representative via email that the fibertaks from an ar-2600fsb-3 fibertak speed bridge implant system pulled out; the anchors did not bunch up.The case was completed using a swivelock.This was discovered during a revision rcr procedure on (b)(6) 2024.The original rcr procedure was performed on (b)(6) 2024.Both surgeries were performed by the same surgeon and at the same facility.In the original procedure, three medial-row swivelocks and three lateral-row swivelocks were implanted.Nothing was explanted during the revision.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation 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(s) of the reported failure can be user error, such as improper bone preparation and/or following the device's correct surgical technique.

• Brand Name: FBRTK SPDBRG IMP SYS W/ BC SWVLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADEABLE, 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: jared engle ; 8009337001
• MDR Report Key: 19466239
• Report Number: 1220246-2024-04898
• Device Sequence Number: 3394408
• Product Code: MBI
• UDI-Device Identifier: 00888867429871
• UDI-Public: 00888867429871
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• 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,Followup
• Report Date (Section B): 10/02/2024

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 Model Number: FBRTK SPDBRG IMP SYS W/ BC SWVLK
• Device Catalogue Number: AR-2600FSB-3
• Device Lot Number: 15230819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown