MAUDE Adverse Event Report: ARTHREX, INC. LNT IMPLANT SYSTEM, 3.9 BC SWIVELOCK; K192532

Model Number	LNT IMPLANT SYSTEM, 3.9 BC SWIVELOCK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by facility representative that an ar-1665bcsl-39 anchor broke upon insertion.This was during a procedure on (b)(6) 2022.The surgeon removed the anchor and used a new ar-1665bcsl-39 to complete the case with no patient harm.
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: LNT IMPLANT SYSTEM, 3.9 BC SWIVELOCK
• Common Device Name: K192532
• 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: 13684537
• Report Number: 1220246-2022-04556
• Device Sequence Number: 6284380
• Product Code: MAI
• UDI-Device Identifier: 00888867367272
• UDI-Public: 00888867367272
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K192532
• 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): 03/07/2022

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 Model Number: LNT IMPLANT SYSTEM, 3.9 BC SWIVELOCK
• Device Catalogue Number: AR-1665BCSL-39
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown