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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET; ARTHROSCOPE Back to Search Results
Model Number 4100062000
Device Problems Material Disintegration (1177); Fluid/Blood Leak (1250)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2020
Event Type  malfunction  
Event Description
The user facility reported the device was leaking during testing prior to a procedure. there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Additional information: d10 device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The user facility reported the device was leaking 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
WIRE COLLET
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9766518
MDR Text Key181768518
Report Number0001811755-2020-00560
Device Sequence Number1
Product Code HRX
UDI-Device Identifier04546540068354
UDI-Public04546540068354
Combination Product (y/n)N
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/07/2020
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
Device Operator No Information
Device Model Number4100062000
Device Catalogue Number4100062000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Initial Date Manufacturer Received 02/25/2020
Initial Date FDA Received02/27/2020
Supplement Dates Manufacturer Received10/06/2020
Supplement Dates FDA Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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