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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.
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Manufacturer (Section D)
11400 73rd ave n
maple grove MN
Manufacturer Contact
jason anderson
11400 73rd ave n
maple grove, MN 55446
MDR Report Key6132400
MDR Text Key61033812
Report Number2134070-2016-00085
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTR375-564-000
Device Catalogue NumberSTR375-564-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2016
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