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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.019.007
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 09/13/2020
Event Type  Injury  
Manufacturer Narrative
Reporter is a j&j employee. (b)(4). The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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) 2020 during a humerus intramedullary nail procedure, the connecting screw broke during nail insertion. The nail was implanted but the direction of the locking screw position was not at the correct place. The instrument broke when the nail's end was reach at the entry point. The broken part of the screw was left intact inside the nail at the end. It could not be removed from the patient during surgery because a proper instrument for removal was not available. The removal attachment could not be attached inside the nal as it was blocked by the broken part of the screw at the thread. There was a surgical delay of fifty (50) minutes. The procedure was successfully completed. The patent outcome is unknown. Concomitant device reported: unknown multiloc humeral nail (part# unknown, lot# unknown, quantity 1). This report is for one (1) connecting screw/cannulated for multiloc humeral nail. This is report 1 of 1 for (b)(4).
 
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Brand NameCONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL
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 Key10629683
MDR Text Key214640154
Report Number8030965-2020-07717
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.007
Device Lot Number9722107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2015
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: 10/05/2020 Patient Sequence Number: 1
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