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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 Patient Involvement (2645)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that during service conducted at the manufacturer a broken pin was found inside the handpiece.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
 
Manufacturer Narrative
The definitive root cause could not be determined as only a partial piece of the device was returned.The quality investigation is closed.
 
Event Description
It was reported that during service conducted at the manufacturer a broken pin was found inside the handpiece.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
 
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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 Key7822405
MDR Text Key118423664
Report Number0001811755-2018-01626
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/27/2018
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 Other
Device Catalogue NumberUNK_ICO
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Initial Date Manufacturer Received 08/01/2018
Initial Date FDA Received08/28/2018
Supplement Dates Manufacturer Received09/27/2018
Supplement Dates FDA Received09/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(B)(4); (B)(4)
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