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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOLUTION AWL/WITHOUT SLEEVE

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OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOLUTION AWL/WITHOUT SLEEVE Back to Search Results
Catalog Number 03.835.032
Device Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2020
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 synthes reports an event in (b)(6) as follows: it was reported that during an anterior lumbar interbody fusion procedure on (b)(6) 2020, a synfix® evolution awl/without sleeve was noted to be blunt. The surgeon attempted to use a second synfix® evolution awl/without sleeve that was observed to be blunt. The surgeon was unsuccessful in using the synfix® evolution awl/without sleeve. There was no surgical delay. The procedure was successfully completed. There was no patient consequence. Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity unknown). This complaint involves two (2) devices. This report is for one (1) synfix® evolution awl/without sleeve. This is report 2 of 2 for (b)(4).
 
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Brand NameSYNFIX EVOLUTION AWL/WITHOUT SLEEVE
Type of DeviceAWL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key10067151
MDR Text Key191334055
Report Number8030965-2020-03564
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeAS
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 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.835.032
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 Received07/03/2020
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: 05/18/2020 Patient Sequence Number: 1
Treatment
UNK - SCREWS: TRAUMA
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