MAUDE Adverse Event Report: ARTHREX, INC. LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
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 04/11/2024, it was reported by a sales representative via (b)(4) that an ar-1665bcsl lnt implant system was manufactured backwards, causing bar to face up instead of down, leading to breakage and difficulty passing suture.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the jaws were assembled incorrectly.The jaws of the assembly suture lasso loop tack did not meet assembly per drawing c19771 rev 0, page 2, note 4-"inspect that jaws are oriented as shown when device is in fully deployed position".Functional testing reveals that the jaws did not show the correct orientation when deployed.The cause of this failure is a manufacturing issue.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the jaws were assembled incorrectly.The jaws of the assembly suture lasso loop tack did not meet assembly per drawing c19771 rev 0, page 2, note 4-"inspect that jaws are oriented as shown when device is in fully deployed position".Functional testing reveals that the jaws did not show the correct orientation when deployed.The cause of this failure is a manufacturing issue.Refer to (b)(4) for details.

• Brand Name: LNT IMPLANT SYSTEM, 4.75 BC SWIVELOCK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19261462
• Report Number: 1220246-2024-02905
• Device Sequence Number: 2582439
• Product Code: MAI
• UDI-Device Identifier: 00888867367265
• UDI-Public: 00888867367265
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191226
• 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,Followup,Followup
• Report Date (Section B): 10/08/2024

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, 4.75 BC SWIVELOCK
• Device Catalogue Number: AR-1665BCSL
• Device Lot Number: 15196869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 09/26/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2024
• 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
• Patient Sex: Unknown