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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; PLATE, FIXATION, BONE
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STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 703896
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that in performing surgery on patient's left radius, the drill bit sheared while drilling a screw hole.The rep reported that another drill bit was immediately available, the case was completed successfully, and no intra operative delay occurred.The piece which broke off in the patient was confirmed by the surgeon via post-op x-ray.Surgeon reported that there is no harm to the patient by leaving it in the bone.The remainder of the drill bit is available for return, but rep reported that x-rays, medical records, and further information are not available due to surgeon policy.
 
Manufacturer Narrative
The reported event that (b)(6) was alleged of "breakage" could be confirmed.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the instrument has been broken apart between the two flute elements.The dull appearance of the damage area suggests a ductile overload fracture caused by an excessive force.A review of the device inspection record 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
It was reported that in performing surgery on patient's left radius, the drill bit sheared while drilling a screw hole.The rep reported that another drill bit was immediately available, the case was completed successfully, and no intra operative delay occurred.The piece which broke off in the patient was confirmed by the surgeon via post-op x-ray.Surgeon reported that there is no harm to the patient by leaving it in the bone.The remainder of the drill bit is available for return, but rep reported that x-rays, medical records, and further information are not available due to surgeon policy.
 
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Brand Name
DRILL BIT, AO DIA2.0MM X 135MM, SCALED
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7177106
MDR Text Key96944468
Report Number0008031020-2018-00033
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number703896
Device Lot NumberAH06/BB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2017
Initial Date FDA Received01/09/2018
Supplement Dates Manufacturer Received03/07/2018
Supplement Dates FDA Received04/03/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
Patient Weight64
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