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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AWL WITH PALM HANDLE

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OBERDORF SYNTHES PRODUKTIONS GMBH AWL WITH PALM HANDLE Back to Search Results
Catalog Number 388.656
Device Problem Break (1069)
Patient Problems Fatigue (1849); Nerve Damage (1979); Paresis (1998); Weakness (2145); Injury (2348); Hypoesthesia (2352); Decreased Sensitivity (2683); No Code Available (3191); Unspecified Tissue Injury (4559)
Event Date 06/18/2014
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported on september 15, 2020, that the patient had an unknown surgery on an unknown date of the year of 2014. During the surgery, the instrument was broken off which ripped dura. It was unknown the surgery completed successfully. Over the time, the patient consequences was nerve damage. This complaint involves one (1) device. This report is for (1) awl with palm handle. This is report 1 of 1 for (b)(4).
 
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Brand NameAWL WITH PALM HANDLE
Type of DeviceAWL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10600930
MDR Text Key209003057
Report Number8030965-2020-07504
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number388.656
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 Received11/13/2020
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

Patient Treatment Data
Date Received: 09/29/2020 Patient Sequence Number: 1
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