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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL Back to Search Results
Catalog Number UNK_ICO
Device Problems Fitting Problem (2183); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported by the customer that during processing the blade jumped out of the handpiece saw and took a piece of metal out.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
H6: the quality investigation is complete.H3 other text : device not returned.
 
Event Description
It was reported by the customer that during processing the blade jumped out of the handpiece saw and took a piece of metal out.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
BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key11015170
MDR Text Key221824319
Report Number0001811755-2020-03439
Device Sequence Number1
Product Code GFA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_ICO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
7207003000 SN (B)(6); 7207003000 SN 1732615893
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