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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN DRILL BIT IMPLANT

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STRYKER GMBH UNKNOWN DRILL BIT IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Fracture
Event Date 12/01/2019
Event Type  Injury  
Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned, and no other evidences were provided. The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. A review of the labeling did not indicate any abnormalities. If the device is returned or if any additional information is provided, the investigation will be reassessed. Device not available for return. Disposed by hospital.

 
Event Description

It was reported: it was reported that a drill bit broke off in a patient's femur.

 
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Brand NameUNKNOWN DRILL BIT
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key9555901
Report Number0008031020-2020-00092
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_SEL
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
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

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