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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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STRYKER GMBH TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 45-27010
Device Problem Break (1069)
Patient Problem Perforation (2001)
Event Date 09/28/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The tip of the drill breaks during operation of the skull distal osteosynthesis.The drill passed through the skin on the other side.
 
Manufacturer Narrative
The reported event that twist drill, diam.2.0x102mm, wl 50mm, ao-shaft was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate angulation and too much applied force of the drill bit.The device inspection revealed the following: the visual inspection of the returned twist drill shows deformations of the flutes which indicate that the drill was stuck and got damaged during reverse cycle.The deformed flutes of the smaller part indicates that as well.Note that the shaft is also bent which lead us believe that far too much force had been applied during drilling.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
 
Event Description
The tip of the drill breaks during operation of the skull distal osteosynthesis.The drill passed through the skin on the other side.
 
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Brand Name
TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8010757
MDR Text Key125192291
Report Number0008031020-2018-00905
Device Sequence Number1
Product Code LXH
UDI-Device Identifier04546540645791
UDI-Public04546540645791
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 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/23/2023
Device Catalogue Number45-27010
Device Lot NumberAH12/BB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2018
Initial Date Manufacturer Received 09/28/2018
Initial Date FDA Received10/26/2018
Supplement Dates Manufacturer Received12/04/2018
Supplement Dates FDA Received12/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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