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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; DRIVER, WIRE, AND BONE DRILL, MANUAL
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STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number UNK_INS
Device Problem Unintended Power Up (1162)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2020
Event Type  malfunction  
Event Description
It was reported that a handpiece, in use with an unknown codman perforator, plunged and ran unexpectedly during a procedure at the user facility outside of the surgical site.The procedure was completed successfully following a 5-minute delay with no impact to the patient, and no medical intervention or adverse consequences reported.
 
Manufacturer Narrative
H3 other text : device not returned.
 
Event Description
It was reported that a handpiece, in use with an unknown codman perforator, plunged and ran unexpectedly during a procedure at the user facility outside of the surgical site.The procedure was completed successfully following a 5-minute delay with no impact to the patient, and no medical intervention or adverse consequences reported.
 
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Brand Name
UNKNOWN_INSTRUMENTS_PRODUCT
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key10305573
MDR Text Key200810836
Report Number0001811755-2020-01772
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_INS
Was Device Available for Evaluation? No
Date Manufacturer Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
5407100000 HANDPIECE, SN (B)(6).
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