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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; PIN, FIXATION, SMOOTH
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STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; PIN, FIXATION, SMOOTH Back to Search Results
Catalog Number UNK_ICO
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/15/2018
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Product not available for return.
 
Event Description
Per medwatch report (b)(4); it was reported that during a right hip arthroplasty surgical procedure, it was noted that the k-wire broke in the patient.It was also reported that a x-ray was performed.It was further reported that the broken piece was successfully removed from the patient.It was also reported that the procedure was completed successfully with no adverse consequences to the patient.
 
Event Description
Per medwatch report (b)(4); it was reported that during a right hip arthroplasty surgical procedure, it was noted that the k-wire broke in the patient.It was also reported that a x-ray was performed.It was further reported that the broken piece was successfully removed from the patient.It was also reported that the procedure was completed successfully with no adverse consequences to the patient.
 
Manufacturer Narrative
The quality investigation is complete.
 
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Brand Name
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Type of Device
PIN, FIXATION, SMOOTH
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7592526
MDR Text Key110848389
Report Number0001811755-2018-01057
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/27/2018
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 Health Professional
Device Catalogue NumberUNK_ICO
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/16/2018
Initial Date FDA Received06/12/2018
Supplement Dates Manufacturer Received07/25/2018
Supplement Dates FDA Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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