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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH STANDARD DRILL BIT ANCHORAGE Ø2.0MM / L110MM, AO; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
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STRYKER GMBH STANDARD DRILL BIT ANCHORAGE Ø2.0MM / L110MM, AO; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS Back to Search Results
Catalog Number XFO082001
Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem Alteration In Body Temperature (2682)
Event Date 03/28/2019
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
During foot surgery using the anchorage 1, lisfranc plate.The surgeon had drilled 4 holes, on the fifth the 2.0mm drill bit broke in the bone.The drill bit was deep in the bone so it was declared safe to leave in the bone by the surgeon.Surgical delay was minimal as the surgeon knew the drill could not be removed.
 
Event Description
During foot surgery using the anchorage 1, lisfranc plate.The surgeon had drilled 4 holes, on the fifth the 2.0mm drill bit broke in the bone.The drill bit was deep in the bone so it was declared safe to leave in the bone by the surgeon surgical delay was minimal as the surgeon knew the drill could not be removed.
 
Manufacturer Narrative
Device evaluation is still pending.A review of the device history did not reveal 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.Upon completion of evaluation, additional information will be provided in a supplemental report.
 
Event Description
During foot surgery using the anchorage 1, lisfranc plate.The surgeon had drilled 4 holes, on the fifth the 2.0mm drill bit broke in the bone.The drill bit was deep in the bone so it was declared safe to leave in the bone by the surgeon.Surgical delay was minimal as the surgeon knew the drill could not be removed.
 
Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Based on investigation, the root cause was attributed to be due to the normal wear of the device.The device was manufactured almost 4 years prior to the reported event.The device inspection of the parts of the drill showed that the device has some scratches and traces of wear.Moreover, signs of extensive re-sterilization/re-cleaning and marks of rust, color fading were also noticed.Furthermore, the breakage reported can be confirmed, as the tip of the device is broken.The microscope images showed a shiny fracture surface, a sign that the two broken parts of the device rubbed against each other.This observation proves that the fracture is due to the fatigue of the material.Most likely, an excessive cyclic loading was applied to the device leading to a final breakage.The device was in use for almost 4 years before the reported incident.Therefore, normal wear could have lead to such an event.
 
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Brand Name
STANDARD DRILL BIT ANCHORAGE Ø2.0MM / L110MM, AO
Type of Device
SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8527701
MDR Text Key142754954
Report Number0008031020-2019-00360
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07613252265511
UDI-Public07613252265511
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,Followup
Report Date 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Catalogue NumberXFO082001
Device Lot NumberJ34726
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Date Manufacturer Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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