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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ADJUSTABLE PIN COLLET (2.0-3.2MM); ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO ADJUSTABLE PIN COLLET (2.0-3.2MM); ARTHROSCOPE Back to Search Results
Model Number 4100126000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/17/2020
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device overheated during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Additional information: d10.Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the device overheated during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
ADJUSTABLE PIN COLLET (2.0-3.2MM)
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10663693
Report Number0001811755-2020-02653
Device Sequence Number14342120
Product Code HRX
UDI-Device Identifier04546540377982
UDI-Public04546540377982
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K943323
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/11/2020
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
Operator of Device Health Professional
Device Model Number4100126000
Device Catalogue Number4100126000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2020
Initial Date Received by Manufacturer 09/17/2020
Supplement Date Received by Manufacturer11/11/2020
Initial Report FDA Received Date10/12/2020
Supplement Report FDA Received Date11/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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