• 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 8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER 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 8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.016.034S
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Patient Involvement (2645)
Event Date 11/26/2018
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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) 2018, during an open reduction internal fixation a proximal humeral nail (phn) multiloc in question was applied to surgery for surgical neck fractures of the right humerus and an unknown connection screw with an unknown aiming arm was loosed for about 1. 5-2 cycles. After fixing the proximal part of the nail with three (3) multiloc screws, the surgeon tried to drill the bone for the most distal screw. However, an unknown drill bit interfered with the nail. The surgeon re-tightened the connecting screw with the aiming arm further and drilled the bone for the second distal screw. At that time, interference did not occur, and the screw was inserted into the nail successfully. The surgeon retried to drill the bone for the most distal screw. However, interference occurred again, and the drill bit went out of the nail. Then, the surgeon drilled the anterior side of the cortical bone and hammered the drill bit carefully. The drill bit successfully passed through the hole on the nail. The screw was inserted into the hole properly. The surgeon commented that when the connection screw was re-tightened with the aiming arm, it was noticed that the connection screw was loose for about 1. 5-2 cycles. In addition, when the surgeon checked the devices out of the patient, there were no problems identified. The surgery was successfully completed with the nail in question successfully implanted and was delayed by more than thirty minutes due to the reported event. The patient was stable after the procedure. There was no adverse consequence to the patient. Concomitant devices reported: unknown distal locking screw (part #: unknown, lot #: unknown, quantity: 1) unknown hammer (part #: unknown, lot #: unknown, quantity: 1). This complaint involves two (2) devices. This report is 1 of 2 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER
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
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8171848
MDR Text Key130637609
Report Number8030965-2018-59112
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.034S
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
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

-
-