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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC DRILL

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ACUMED LLC DRILL Back to Search Results
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/22/2016
Event Type  Injury  
Event Description
While implanting a polarus 3 nail, the drill was flexed during drilling and the tip broke off in the bone. The tip was left implanted.
 
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Type of DeviceDRILL
Manufacturer (Section D)
ACUMED LLC
5885 nw cornelius pass road
hillsboro OR 97124 9432
Manufacturer (Section G)
ACUMED LLC
5885 nw cornelius pass road
hillsboro OR 97124 9432
Manufacturer Contact
micki lehman
5885 nw cornelius pass road
hillsboro, OR 97124-9432
5036279957
MDR Report Key6303918
MDR Text Key66596734
Report Number3025141-2017-00017
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K131636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received12/21/2016
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 Unkown

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