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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NAV PIN 3MM X 100MM CASE OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NAV PIN 3MM X 100MM CASE OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007003100
Device Problem Fracture (1260)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility a surgical pin snapped while doing a keel punch.The device was left in the patient.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Event Description
It was reported that during a procedure at the user facility a surgical pin snapped while doing a keel punch.The device was left in the patient.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device was not available for evaluation.H3 other text : no product return per the customer.
 
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Brand Name
NAV PIN 3MM X 100MM CASE OF 10
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12510109
MDR Text Key272645470
Report Number3015967359-2021-02055
Device Sequence Number1
Product Code HAW
UDI-Device Identifier57613154107396
UDI-Public57613154107396
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6007003100
Was Device Available for Evaluation? No
Date Manufacturer Received10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
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