MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2023
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) 2023, it was reported by a sales representative via phone that an ar-1593-bc swivelock driver began to twist around proximal portion of anchor and would not seat anchor, anchor did fracture.This was discovered during a case , device breaks during use.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the reported event allegation is not confirmed without the device being returned or any photo provided.The patient's bone density was reported as hard.The most likely cause for the reported failure can be attributed to user error due to the use of an oversized 5.5mm swivelock per customer information.This is not recommended for use with a 4.75mm anchor, as the thread form will be misaligned/damaged if this tap is used with a 4.75mm anchor.

• Brand Name: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 17011893
• Report Number: 1220246-2023-06793
• Device Sequence Number: 15344973
• Product Code: MAI
• UDI-Device Identifier: 00888867331310
• UDI-Public: 00888867331310
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• 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
• Report Date (Section B): 06/11/2024

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: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Device Catalogue Number: AR-1593-BC
• Device Lot Number: 15062403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2023
• 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