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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.030
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/11/2019
Event Type  Injury  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 on (b)(6) 2019, the surgeon attempted to remove tfna blade. Pt had extremely hard bone. Tried to remove lag screw with instrument and the tip snapped in the end of the lag screw. Unable to remove in (b)(6) so patient closed up. Broken item left inside lag screw. Waited to receive loan set back from the hospital to inspect instrument. Hospital in a remote location. Tfna inserted in vic in 2014. There were fragments generated from a broken device and were not removed. There was a surgical delay with unknown number of minutes. Concomitant device reported: unknown tfna lag screw (part number unknown, lot number unknown, quantity: 1). This report is for one (1) helical blade/screw extractor. This is report 1 of 1 for (b)(4).
 
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Brand NameHELICAL BLADE/SCREW EXTRACTOR
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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
6103142063
MDR Report Key8878961
MDR Text Key153829137
Report Number8030965-2019-67055
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.030
Device Lot NumberL423668
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/09/2019 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEM: TFNA LAG SCREW
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