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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH POWER DRIVE
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SYNTHES GMBH POWER DRIVE Back to Search Results
Catalog Number 530.100
Device Problems Overheating of Device (1437); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer reported that the device worked intermittently and got hot.This is report 1 of 1 for event # (b)(4).
 
Manufacturer Narrative
Additional narrative: synthes is submitting this report as a result of remediation activities related to synthes 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.During pre-repair assessment performed by technician, the functional testing revealed that the device did not function properly.Device was inspected, and repaired by replacing a few components.Placeholder.
 
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Brand Name
POWER DRIVE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
ch-4436
oberdorf
SZ 
Manufacturer (Section G)
SYNTHES GMBH
eimattstrasse 3
ch-4436
oberdorf
SZ  
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key4209681
MDR Text Key4982288
Report Number8030965-2014-01752
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/02/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number530.100
Device Lot Number2851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received07/02/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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