MAUDE Adverse Event Report: ARTHREX, INC. TKL SPDBRG IMP SYS W/ BC SWVLK & NDL; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
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) 2021, it was reported by a sales representative via e-mail that an ar-2600sbs-10 speedbridge implant system suture broke off from the eyelet before the surgeon could pull the inserter out.This was discovered during a procedure on (b)(6) 2021.The case was completed by using a new ar-2600sbs-10.

• Brand Name: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12616437
• Report Number: 1220246-2021-03782
• Device Sequence Number: 3973283
• Product Code: MBI
• UDI-Device Identifier: 00888867369658
• UDI-Public: 00888867369658
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: 01/31/2025
• Device Model Number: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-10
• Device Lot Number: 12893109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1