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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BOLT Ø3.4 SELF-TAP L44 TAN VIOL ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH BOLT Ø3.4 SELF-TAP L44 TAN VIOL ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 462.444
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/03/2018
Event Type  malfunction  
Manufacturer Narrative
Patient age, date of birth, and weight not available for reporting. Device is not distributed in the united states, but is similar to device marketed in the usa. Udi and 510k not available. Device malfunctioned intra-operatively and was not implanted/explanted. (b)(6). A review of the device history records has been requested. Subject device has been received and is currently in the evaluation process. 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 europe reports an event in (b)(6) as follows: it was reported that during a procedure to implant a solid humeral nail on (b)(6) 2018, the 3. 4mm locking bolt bent at the moment of compression. Surgery was completed successfully with no delay. Patient status reported as stable. Concomitant devices reported: solid humeral nail (part number unknown, lot number unknown, quantity 1), screwdriver (part number unknown, lot number unknown, quantity 1). This report is for one (1) 3. 4mm solid humeral nail. This is report 1 of 1 for (b)(4).
 
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Brand NameBOLT Ø3.4 SELF-TAP L44 TAN VIOL
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
michael cote
6107195000
MDR Report Key7546135
MDR Text Key109314902
Report Number8030965-2018-53987
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodePE
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 05/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number462.444
Device Lot Number1476670
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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