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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG ADAPT 2.0 FOR GAMMA3 SW ORTHOPEDIC STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-FREIBURG ADAPT 2.0 FOR GAMMA3 SW ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 0101-2900
Device Problems Image Display Error/Artifact (1304); Incorrect Measurement (1383)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
During testing of the device, significant misrepresentations and mis-measurements occurred. The device is reported to be new. Surgical delay of 30min. Not longer. This resulted in triple increase in radiation exposure, normally radiation time for gamma3 nail in this hospital is 12-13 seconds, in this surgery 40 seconds. No other patient impact.
 
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Brand NameADAPT 2.0 FOR GAMMA3 SW
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
D-79111
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
D-79111
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9417005
MDR Text Key169267816
Report Number0008031020-2019-02033
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K173946
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0101-2900
Device Catalogue Number0101-0001
Device Lot NumberV2.0-13
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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