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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS E12 ELECTRIC MOTOR; DRILLS, BURRS, TREPHINES & ACCESSORIES - HANDPIECE
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DEPUY SYNTHES POWER TOOLS E12 ELECTRIC MOTOR; DRILLS, BURRS, TREPHINES & ACCESSORIES - HANDPIECE Back to Search Results
Catalog Number E12
Device Problems Component Missing (2306); Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer sent the device in for repair.The strain relief bushing was missing and wires were exposed.(b)(4).
 
Manufacturer Narrative
Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Serial # updated to (b)(4).Mfg date 03/16/2010.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Device was repaired and returned to the customer.
 
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Brand Name
E12 ELECTRIC MOTOR
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES - HANDPIECE
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
4500 riverside drive
palm beach gardens 33410
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
4500 riverside drive
palm beach gardens 33410
Manufacturer Contact
rodney crain
4500 riverside drive
palm beach gardens, FL 33410
5616271080
MDR Report Key4181075
MDR Text Key18258736
Report Number1045834-2014-14499
Device Sequence Number1
Product Code HBE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK040076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/26/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received12/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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