MAUDE Adverse Event Report: ARTHREX, INC. SHAVER HP, APSII, HAND CONTROL; POWERED SURG ORTHOPEDIC INSTR

Model Number SHAVER HP, APSII, HAND CONTROL

Device Problems Explosion (4006); Unexpected Shutdown (4019)

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

Event Date 10/05/2023

Event Type  malfunction  

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 Description

On 10/05/2023, it was reported by a facility representative via sems-06050473 that an ar-8305 synergy resection shaver console made a loud boom sound and then the device blew up.The patient was not affected.This was discovered during an unspecified procedure, with no reported patient harm.Additional information requested.

Manufacturer Narrative

Additional info: b5 corrected data: h2 reportable event to 'na', h6 fields updated.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

Event Description

On 10/5/2023, it was reported by a facility representative via sems-06050473 that an ar-8305 synergy resection shaver console made a loud boom sound and then the device blew up.The patient was not affected.This was discovered during an unspecified procedure, with no reported patient harm.Additional information received on 11/16/2023: it was stated via e-mail that the ar-8305 synergy resection shaver console stopped working (turned off) and could not power back up.The console did not "blow up.".

• Brand Name: SHAVER HP, APSII, HAND CONTROL
• 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: 18012038
• MDR Text Key: 326622078
• Report Number: 1220246-2023-08392
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867043237
• UDI-Public: 00888867043237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SHAVER HP, APSII, HAND CONTROL
• Device Catalogue Number: AR-8330H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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