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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM UNIVERSAL DRILL GUIDE
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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM UNIVERSAL DRILL GUIDE Back to Search Results
Catalog Number 323.360
Device Problems Misassembled (1398); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2018
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Patient information is not available for reporting.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.Device was used for treatment, not diagnosis.
 
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that patient underwent clavicle planting on (b)(6) 2018.During the procedure the (2.5mm) drill bit got stuck in the drill sleeve.(2.4mm) drill guide may have been used and not the (2.5mm) drill guide.It is unknown if the procedure was successful.Patient outcome is unknown.This complaint involves two (2) devices.This report is 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 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.Additional narrative: date rec¿d by mfr.Device evaluated by mfr, device manufacture date: a device history record (dhr) review was conducted: part: 323.360, lot: l790665, manufacturing site: hägendorf, release to warehouse date: 16.May.2018.The device history record shows this lot of 48 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Device evaluated by mfr: a product investigation was conducted.Visual inspection: upon visual inspection of the complaint devices it can be seen that the two parts (drill bit and drill guide) stick together, this thus confirming the complaint description.Otherwise the received articles are in a good condition.Functional test: a functional test is not possible, based on the received condition, and as we are not able to separate those parts from each other.Document/specification review: drawings and revisions are in accordance to dhr's.All relevant features are defined on the used drawing revisions of dhr's.Dimensional inspection: drill guide: to measure the position of the involved section, isn't possible based on the received condition, and as we are not able to separate those parts from each other.Drill bit: the diameter was measured with the micrometre per relevant drawing, the measure result is within accuracy.Summary: there is no particularize information what's happened to these articles by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place or/and that by drilling "foreign material / soft tissue" got stuck within those parts what have caused this error.To prevent such problems, it is necessary worn or damaged instruments to replace.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: date of report, date rec¿d by mfr: the incorrect date was inadvertently utilized in initial; medwatch.The correct date is september 17, 2018.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
It was reported that here was no surgical delay and nothing abnormal reported about the patient.
 
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.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
3.5MM UNIVERSAL DRILL GUIDE
Type of Device
GUIDE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key7940772
MDR Text Key123373010
Report Number8030965-2018-57040
Device Sequence Number1
Product Code FZX
UDI-Device Identifier07611819021204
UDI-Public(01)07611819021204
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,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number323.360
Device Lot NumberL790665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2018
Date Manufacturer Received11/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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