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

Model Number	IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2021
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
It was reported during a patella tendon repair the green handle tap became loose and was just spinning.The handle had to be sawed off and then the tap was removed after chucking it up to the drill then running it in reverse.All was removed and the case was completed with no further issues.The patient is fine to date.The patient was (b)(6) and the bone quality was very hard.

• Brand Name: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12032531
• Report Number: 1220246-2021-03302
• Device Sequence Number: 19939448
• Product Code: MAI
• UDI-Device Identifier: 00888867331310
• UDI-Public: 00888867331310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/21/2021

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: 03/31/2025
• Device Model Number: IMPLSYS 2NDRY FIXATN BIOSWVLK 4.75X19.1
• Device Catalogue Number: AR-1593-BC
• Device Lot Number: 13243643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1