• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTSCR F/TIBIAL+FEM NAILS ROD, FIXATION, INTRAMEDULLARY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTSCR F/TIBIAL+FEM NAILS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.010.000
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Code Available (3191)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number, the device history records review could not be completed as no product was received. (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 synthes reports an event in (b)(6) as follows: it was reported that the 5th of november during a surgery, the instrument to remove a nail with did not work as expected. In practice, the nail removal instrument had been practically unthreaded and the question was whether we checked the instruments before surgery. The surgery was unsuccessful because it was a mere removal instrumentation and no other depreciation option was available. Therefore the surgery had to be stop. The instrument item 03. 010. 00011008800 lk, module stqetsnn-4, did not work during surgery. Concomitant device reported: unk - nail: expert tibial (part# unknown; lot# unknown; quantity 1). This complaint involves one (1) device. This report is for one (1) extractscr f/tibial+fem nails. This report is 1 of 2 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXTRACTSCR F/TIBIAL+FEM NAILS
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
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9354878
MDR Text Key185490368
Report Number8030965-2019-70476
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFI
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 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.000
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 Received12/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/21/2019 Patient Sequence Number: 1
-
-