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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; BIT, DRILL

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OBERDORF SYNTHES PRODUKTIONS GMBH; BIT, DRILL Back to Search Results
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown unk - drill bits: trauma/unknown lot.Part and lot number are unknown; udi number is unknown.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.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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.
 
Event Description
It was reported that on (b)(6) 2019, a patient underwent an open reduction internal fixation (orif) with expert antigrade femoral nail (afn) for femoral diaphyseal fractures.When the surgeon tried to insert an unknown locking screw for proximal side topping under static transverse mode, an unknown drill bit interfered with an unknown nail.Thus, the surgeon gave up with the static transverse mode and inserted the locking screw under dynamic mode.Eventually, the surgery was completed with no surgical delay.There was no adverse consequence to the patient.Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity 1); unknown afn nail (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for one (1) unk - drill bits.This report is 2 of 2 for (b)(4).
 
Manufacturer Narrative
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.
 
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Type of Device
BIT, DRILL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8406004
MDR Text Key138401940
Report Number8030965-2019-61861
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Initial Date Manufacturer Received 02/14/2019
Initial Date FDA Received03/08/2019
Supplement Dates Manufacturer Received05/06/2019
Supplement Dates FDA Received05/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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