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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/18/2022, it was reported by a sales representative via email that an multifire scorpion needle tip, from an ar-2600sbs-10 knotless speedbridge implant system, was found to be broken off, on the 6th pass attempt.After spending some time looking for the tip of the needle, an x-ray had to be taken to help find the broken fragment.The multifire scorpion needle tip was found outside of the patient, and it was confirmed via x-ray that nothing was left inside the patient.Case was completed by opening an ar-7281 free needle.This was discovered during an open rcr procedure on (b)(6) 2022.Additional information received on 1/4/2023: per the sales representative, patient spent an additional thirty minutes under anesthesia while surgeon was looking for the broken needle tip.
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.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16223176
• Report Number: 1220246-2023-06142
• Device Sequence Number: 5351352
• Product Code: MBI
• UDI-Device Identifier: 00888867369658
• UDI-Public: 00888867369658
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/23/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-10
• Device Lot Number: 15001131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 01/23/2023
• Date Device Manufactured: 09/12/2022
• 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