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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
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Patient Involvement (2645)
Event Date 11/26/2018
Event Type  malfunction  
Manufacturer Narrative
510k: this report is for an unknown drill bits: unknown lot.Part and lot number are unknown; udi number is unknown.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 2 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.
 
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Type of Device
BIT, DRILL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8171851
MDR Text Key130637666
Report Number8030965-2018-59114
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 11/26/2018
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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