MAUDE Adverse Event Report: ARTHREX LOGISTIC CENTER ARTHREX SYNERGY RESECTION SJ HAND PIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number AR-8330SJ

Device Problems Mechanical Problem (1384); Problem with Sterilization (1596)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2021

Event Type  Injury  

Event Description

It was identified that the arthrex shaver could not be properly cleaned and sterilized.The cleaning brush was unable to reach deep into the device.Fda safety report id # (b)(4).

• Brand Name: ARTHREX SYNERGY RESECTION SJ HAND PIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX LOGISTIC CENTER
• MDR Report Key: 12561766
• MDR Text Key: 274485311
• Report Number: MW5104307
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR-8330SJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention