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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - DRILL BITS: TRAUMA; BIT,DRILL
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - DRILL BITS: TRAUMA; BIT,DRILL Back to Search Results
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
Pma/510k: this report is for an unknown 4.3mm drill bit/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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 double osteotomy tomofix procedure on (b)(6) 2020, surgeon complained that 4.3mm and 3.2mm drill bits were blunted and were impacting procedure due to pressure applied to power tool.Per surgeon it was not hard enough bone to create issue.There was a surgical delay of ten (10) minutes.Osteotomy had lost reduction/alignment.Screw removal and 2nd reduction, place replacement required.The procedure was successfully completed.This report is for one (1) unknown 4.3mm drill bit.This is report 1 of 2 for complaint (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.
 
Event Description
This is report 1 of 3 for complaint (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.
 
Event Description
Initial procedure, blunt drill pushed osteotomy out of alignment/reduction.Had to remove all screws and plate to gain reduction again.
 
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Brand Name
UNK - DRILL BITS: TRAUMA
Type of Device
BIT,DRILL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10779909
MDR Text Key214404829
Report Number8030965-2020-08534
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,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
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 Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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