• 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 11.0MM MEDULLARY REAMER HEAD

  • 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 11.0MM MEDULLARY REAMER HEAD Back to Search Results
Catalog Number 352.110
Device Problem Device Operates Differently Than Expected
Event Date 02/09/2018
Event Type  Malfunction  
Manufacturer Narrative

Patient information is unknown. Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A device history record review was requested. 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 the devices were used in surgery for femoral trochanteric fracture on (b)(6) 2018. Without using reaming rod (352. 032) beforehand, the surgeon inserted the assembled reaming unit (composed of 352. 110 reamer head, 352. 040 flexible shaft and 351. 150 t-handle in question) into the medullary cavity. Then, the reamer head came off the flexible shaft around the narrowest medullary cavity. The surgeon re-connected the reamer head and the flexible shaft in the medullary cavity, took the entire reaming unit, and completed the surgery with a ten-minute delay. There was no adverse consequence to the patient, who had no fragment left in her body. It was confirmed that the surgeon had not been given a proper guidance on the reaming-device usage. Concomitant parts: 1 qty, p/n 351. 150, l/n 2088577; 1 qty, p/n 354-5295, l/n 0000657475; this is report 1 of 3 for (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name11.0MM MEDULLARY REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
michael cote
1302 wrights lane east
west chester  
6107195000
MDR Report Key7324833
Report Number8030965-2018-51851
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.110
Device LOT Number2096934
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/04/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-