MAUDE Adverse Event Report: STERILMED, INC.; ARTHROSCOPE

Model Number STR375-564-000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was not reviewed as the lot number reported was not correct.

Event Description

It was reported that the device was being used on a shoulder arthroscopy.While being used, the handpiece and device(while attached) created a loud noise and the staff were able to confirm that the shaver had fragmented, leaving shavings in the patients joint.Micro shavings are still present as it was cleaned out as much as possible.No x-ray was taken.The shavings were visible through the scope video.There was no patient harm or consequences.

Manufacturer Narrative

The device was returned to the manufacturer with heavy contaminants present as well as damage present to the device.A portion of the distal opening in the outer sub-assembly has been broken off.The device likewise fails the spin/drop test with definitive metal on metal contact being detected as the inner is rotated within the outer.The root cause for the damage is linked to the use of the device in the field.Per the account the device emitted a loud noise during use, which may have been linked to excessive pressure being placed on the device during its use.

• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jason anderson ; 11400 73rd ave n; maple grove, MN 55446 ; 7634888348
• MDR Report Key: 6132400
• MDR Text Key: 61033812
• Report Number: 2134070-2016-00085
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STR375-564-000
• Device Catalogue Number: STR375-564-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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