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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 HUMERUS 3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER TRAUMA KIEL DRILL, AO T2 HUMERUS 3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 1806-3540
Device Problem Break (1069)
Patient Problem Laceration(s) (1946)
Event Date 04/26/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
It was reported the drill broke during surgery; the broken bit was fully retrieved from the patient.There was a 30 minute delay in surgery, which did not require additional anesthesia.An incision opposite from and in addition to the nail side was made in order to remove the broken bit.The procedure was completed successfully with a backup device.
 
Manufacturer Narrative
The reported event could be confirmed, since physical evaluation revealed a broken off tip.The drilling spiral of the drill returned is completely sheared off.The broken off piece was not returned.According to the appearance of the breakage surface, the drill broke in a (forced) brittle manner due to overload, most likely by bending stresses.The breakage may be caused by drilling under misalignment and / or contact with a hard object.Based on the above facts the root cause of the reported event is not related to a deficiency of the device but is rather linked to improper handling by the user.The brochure ¿instructions for cleaning, sterilization, inspection and maintenance¿ help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.Broken drills, with remaining parts in patient, are known from previous cases and were evaluated by a medical expert.Excerpts from the clinical assessment of a medical expert in a similar case: ¿an intra-operative breakage of a drill is a rare but common complication and well known to an experienced user.It is caused by twisting the drill and too much bending.Breakage caused by material defect is very rare in current manufacturing technology.It is of interest whether a broken part of a drill can be left in the bone or should be retrieved; also in the case that greater harm to the bone would be done.It is well known to an expert user that a broken part of a drill which is completely embedded in the bone normally does not cause any harm.In absence of a nickel allergy, the material used for the drill does not cause any local or systemic incompatibility.[¿] therefore, no further surgical procedures in this special case are required.[¿]¿ 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.However, it lies in the responsibility of the treating surgeon to leave or to remove the broken off part and according to details available ¿¿finally it was possible to remove the broken piece¿¿.In addition, the risk has been evaluated and is adequately covered in the current valid risk file.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
 
Event Description
It was reported the drill broke during surgery; the broken bit was fully retrieved from the patient.There was a 30 minute delay in surgery, which did not require additional anesthesia.An incision opposite from and in addition to the nail side was made in order to remove the broken bit.The procedure was competed successfully with a backup device.
 
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Brand Name
DRILL, AO T2 HUMERUS 3,5X230 MM
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key11854860
MDR Text Key255127200
Report Number0009610622-2021-00519
Device Sequence Number1
Product Code HWE
UDI-Device Identifier04546540196606
UDI-Public04546540196606
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1806-3540
Device Catalogue Number18063540
Device Lot NumberKU116655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
Date Manufacturer Received07/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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