MAUDE Adverse Event Report: STERILMED, INC.; ARTHROSCOPE

Model Number SMI7205313

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

It was reported that during a right shoulder arthroscopy/rotator cuff resection the device was utilized and at the very beginning of the case shavings began to come off the device in the surgery/wound area.There was no noise or vibration.No side loading took place.The issue really started when the device was first turned on and started to use.The shavings were removed via irrigation and suction.The procedure was finished with another model device from another manufacturer.There was no patient injury.

Manufacturer Narrative

Final device investigation found that the device was returned in good visual condition.Upon evaluation, the device was viewed under magnification.There was no notable damage to the cutting surfaces.Scouring marks were present on the inner subassembly with corresponding marks on the outer shaft indicating that there may have been metal to metal contact during use.However, during testing the inner shaver slid easily into the outer shaft, and there was no metal to metal contact during a spin/drop test.The device connected easily to the generator and spun freely with no metal to metal scraping.No shavings were produced during examination.The alignment of the device was examined and found to be acceptable.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4320055
• MDR Text Key: 20656620
• Report Number: 2134070-2014-00194
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2014

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 Expiration Date: 09/30/2015
• Device Model Number: SMI7205313
• Device Catalogue Number: 7205313
• Device Lot Number: 1796260
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1