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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STRAIGHT CUP REAMER HANDLE STEREOTAXIC DEVICE, ROBOTICS

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STRYKER ORTHOPAEDICS-MAHWAH STRAIGHT CUP REAMER HANDLE STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 207084
Device Problems Degraded (1153); Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available.
 
Event Description
Event description :the issue was that the reamer and the mics attachment stripped the metal on the back of the straight reamer. Case type: tha. Surgical delay:
=
15 minutes.
 
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Brand NameSTRAIGHT CUP REAMER HANDLE
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9237971
MDR Text Key175243061
Report Number3005985723-2019-00761
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number207084
Device Catalogue Number207084
Device Lot Number06021216
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/25/2019 Patient Sequence Number: 1
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