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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

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OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH Back to Search Results
Catalog Number 310.221
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 05/29/2019
Event Type  Injury  
Manufacturer Narrative

Additional pro-code: hsz, gfa, gff. (b)(4). The reported event required medical/surgical intervention to preclude permanent damage to a body structure. Device, component or fragment remains in patient either intentional or unintentional and is embedded within the bone/tissue. A review of the device history record has been requested. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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) 2019, during a scaphoid procedure the surgeon used a cannulated drill bit through an unknown guide wire from a headless compression system by hand. Upon insertion, the drill bit broke and for about 7mm of the broken drill bit was embedded in the patient's bone. The surgeon decided not to remove the broken fragments from the broken device. The surgeon continued inserting another guide wire and drilled a new site. There was a 30 minutes surgical delay, however, the procedure was successfully completed without any problem. There was no patient consequence to the patient reported. Concomitant devices reported: guide wire (part#unknown, lot#unknown, quantity#1). This complaint involves (1) device. This report is 1 of 1 for (b)(4).

 
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Brand Name2.0MM CANNULATED DRILL BIT/QC 150MM
Type of DeviceINSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8737612
MDR Text Key149340369
Report Number8030965-2019-65795
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberEXEMPT
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 05/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number310.221
Device LOT NumberF-16188
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/11/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/26/2019 Patient Sequence Number: 1
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