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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM DRILL BIT W/DEPTH MARK QC/110MM; BIT MILLING STERILE AND NON
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OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM DRILL BIT W/DEPTH MARK QC/110MM; BIT MILLING STERILE AND NON Back to Search Results
Catalog Number 310.534
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/22/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2020, the patient underwent the open reduction internal fixation (orif) surgery for proximal tibial joint fractures.During the surgery, when the surgeon was using the drill bit, the tip of the drill bit broke in the bone and it generated fragment, which was left in the patient¿s body.No screw is inserted in the screw hole where the drill bit remains.The surgery was completed, and no further information is provided.This report is for one (1) 2.0mm drill bit.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: the device was received, the investigation is in progress, 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.
 
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.H3, h6: part: 310.534, lot: 8120207, manufacturing site: bettlach, release to warehouse date: october 19, 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection of the drill bit ø 2.0mm has shown that the tip with the cutting edges is completely broken off.For further investigation, the tip is not available (the broken part remained in the bone, therefore could not be returned).Dimensional inspection: document/drawing: feature/test/description: quick coupling outer diameter results "pass" document/drawing: feature/test/description: shaft outer diameter results "pass" the measured dimensions were found to be within the given specifications per the drawings referenced above.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.The review has shown that with raw materials, the correct material was used.The measurements of the hardness after the hardening procedure were also within the specification.Summary: the complaint is confirmed as the the drill bit tip is broken off.This production lot (8120207) was manufactured in october 2012 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.The broken surface is homogenous which indicates material conformity to the specification as well.Based on these findings,we have to assume that a mechanical overload, either by too much lateral stress or/and an excessive contact with an other instrument caused the breakage.Wear and tear (considering the age of the complained drill bit) may also have played a certain role too.In this relation, we would like to point out that further hints concerning the limits of reprocessing (e.G.End of life of a device) can be found in the important information leaflet.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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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Brand Name
2.0MM DRILL BIT W/DEPTH MARK QC/110MM
Type of Device
BIT MILLING STERILE AND NON
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10025027
MDR Text Key194322281
Report Number8030965-2020-03292
Device Sequence Number1
Product Code GFG
UDI-Device Identifier07611819158962
UDI-Public(01)07611819158962
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number310.534
Device Lot Number8120207
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Initial Date Manufacturer Received 04/22/2020
Initial Date FDA Received05/05/2020
Supplement Dates Manufacturer Received05/26/2020
06/02/2020
Supplement Dates FDA Received05/26/2020
06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight56
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