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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER

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OBERDORF SYNTHES PRODUKTIONS GMBH DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER Back to Search Results
Model Number 314.742
Device Problems Break; Material Fragmentation
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative

This patient information is unknown. Additional device product code: hrx. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter is company representative. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 during an intramedullary canal lavage on (b)(6) 2018, when reaching the fracture point the reamer did not advance, the surgeon applied strength to the reamer but it did not advance. It was found out that the tip of the drive shaft was broken. The surgeon performed an x-ray scan of the entire leg of the patient, and a metal with a different density is evidenced, it is assumed to be the tip of the transmission tree. It was unknown if there was a surgical delay. The surgery was completed successfully. Patient status was unknown. Concomitant device reported: unk - reamer head (part number unknown, lot number unknown, quantity 1). This report is for one (1) drive shaft-minimum 360mm length-for use with ria. This is report 1 of 1 for complaint (b)(4).

 
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Brand NameDRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
Type of DeviceREAMER
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
michael cote
1302 wright lane east
west chester , PA 19380
6107195000
MDR Report Key7641183
Report Number8030965-2018-54653
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial
Report Date 06/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number314.742
Device Catalogue Number314.742
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 Received06/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/27/2018 Patient Sequence Number: 1
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