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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BROCA MATRIXMANDIBLE 1.5 2AREST-CORT P/; DRILL, BONE, POWERED
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OBERDORF SYNTHES PRODUKTIONS GMBH BROCA MATRIXMANDIBLE 1.5 2AREST-CORT P/; DRILL, BONE, POWERED Back to Search Results
Catalog Number 03.503.476S
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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) 2019, during an unknown procedure there was an issue with the trans-buccal drill bits.None would cut and one broke, tips blackened.No fragments were left in the patient.A standard intra-oral drill bit was used as a replacement.This complaint involves four (4) devices.This report is for one (1) matrixmandible 1.5mm drill bit j-latch for 03.503.045/.047.This is report 2 of 4 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).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 history lot mre for sterilization: part number: 03.503.476s, synthes lot number: 1l54318, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 19.Sep.2018, expiry date: 01.Sep.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Mre for non sterile part: 03.503.476 / u305450.Manufacturing location: supplier - orchid / inspection, packaging and release by: monument release to warehouse date(s): 20-mar-2018 quantity 280 / 25-may-2018 quantity 55 / 16-aug-2018 quantity 161 part number: 03.503.476, matrixmandible 1.5mm drill bit j latch for 03.503.045/.047 lot number: u305450 (non-sterile) lot quantity: 496 total (three batches 280, 55 and 161) purchased finished goods travelers met all inspection acceptance criteria.Inspection sheets, incoming final inspection 03if503476 rev j met all inspection acceptance criteria.Certificates of conformance supplied by orchid dated 24-feb-2018 were reviewed and determined to be conforming.Heat treat specified at hrc 50-55; certified hardness value of hrc 50.4.Packaging label logs (pll) lppf rev b were reviewed and determined to be conforming.Note: two batches labeled for usa and one batch labeled for ous (ce mark).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection, packaging or release that would contribute to this complaint condition.Device history batch null, device history review 10-dec-2019: dhr this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.H3, h6: investigation summary the complaint condition that the drill bit did not cut or broke during use, cannot be confirmed according to the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and 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
Update: this report is 3 of 6 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).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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Brand Name
BROCA MATRIXMANDIBLE 1.5 2AREST-CORT P/
Type of Device
DRILL, BONE, POWERED
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9474151
MDR Text Key170951101
Report Number8030965-2019-71128
Device Sequence Number1
Product Code DZI
UDI-Device Identifier07611819351479
UDI-Public(01)07611819351479
Combination Product (y/n)N
PMA/PMN Number
K043310
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 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.503.476S
Device Lot Number1L54318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Date Manufacturer Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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