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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC. ARTHROSCOPE

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STERILMED, INC. ARTHROSCOPE Back to Search Results
Model Number STR375-951-100
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2016
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 unable to be reviewed as no lot number was given.
 
Event Description
It was reported that, during the procedure, shavings were coming off the device and into the patient, all the shavings were not cleaned out. An x-ray was not used to determine this, the surgeon could still see them visually thorough the scope before pulling equipment out and closing the wound. It was reported that there was no patient harm or consequences.
 
Manufacturer Narrative
The account returned pictures showing the devices shedding metal during their use in the field. The devices in question passed all of their functional testing. While we cannot dispute the devices shedding metal during use in the field this could not be reproduced and observed in a laboratory setting. This may be due to the manner in which the device was used in the field, such as coming into contact with an outside element that resulted in the metal shedding. No damage was observed with the out sub-assembly and the device passed its spin/drop test.
 
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Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STERILMED, INC.
11400 73rd ave n
maple grove MN
Manufacturer Contact
jason anderson
5010 cheshire parkway
suite 2
plymouth, MN 55446
7634888348
MDR Report Key6133698
MDR Text Key61084585
Report Number2134070-2016-00088
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012536
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 11/11/2016
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 Other
Device Model NumberSTR375-951-100
Device Catalogue NumberSTR375-951-100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
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

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