MAUDE Adverse Event Report: ARTHREX, INC. APS II SHVR HANDP,FT-SWCH CNTRL; POWERED SURG ORTHOPEDIC INSTR

Model Number APS II SHVR HANDP,FT-SWCH CNTRL

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported that during an arthroscopy the device shows error messages s222 and s52 error hand piece.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

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.

Manufacturer Narrative

(motor) the evaluation confirmed the reported event, "it was reported that during an arthroscopy the device shows error messages s222 and s52 error hand piece.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery." and attributed it to normal wear and tear due to the age of the device.

• Brand Name: APS II SHVR HANDP,FT-SWCH CNTRL
• Type of Device: POWERED SURG ORTHOPEDIC INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17444507
• MDR Text Key: 320246729
• Report Number: 1220246-2023-07404
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867043220
• UDI-Public: 00888867043220
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K932699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

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
• Device Operator: Health Professional
• Device Model Number: APS II SHVR HANDP,FT-SWCH CNTRL
• Device Catalogue Number: AR-8330F
• Device Lot Number: NB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1