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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED

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OBERDORF SYNTHES PRODUKTIONS GMBH MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED Back to Search Results
Catalog Number 03.503.476
Device Problems Break (1069); Device-Device Incompatibility (2919)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/04/2018
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was conducted: manufacturing location: (b)(4), release to warehouse date: 20-nov-2017, release to warehouse date: 27-nov-2017: part number: 03.503.476 matrixmandible 1.5mm drill bit lot #: u287574, lot quantity: (b)(4), lot quantity: (b)(4): purchased finished goods travelers for both batches met all inspection acceptance criteria.Certificates of conformance supplied by (b)(4) dated 07-nov-2017 were reviewed and found to be conforming.Inspection sheets, material review, incoming final inspection 03if503476 rev j met all inspection acceptance criteria.Packaging label logs lppf, lmd/lpf rev ac were reviewed an found to be conforming.These lots met all dimensional, visual and packaging criteria at the time of release with no issues documented that would contribute to this complaint condition.A product investigation was conducted.Device condition: visual inspection performed at customer quality (cq) on the returned drill bit observed the drill bit as broken at its distal tip.The broken portion of device got lodged into the cannula along with the other half portion of the drill bit.No new issues were identified.The broken drill bit was not able to be disassembled from the cannula.The complaint condition was noted to be consistent with the given complaint condition and therefore the complaint was confirmed.Dimensional analysis and document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed and no design issues were identified.Dimensional inspection was not performed on the given device due to stuck condition.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.Certificates of conformance, material review, incoming final inspection were reviewed and found to be conforming.These lots met all dimensional, visual, material and packaging criteria at the time of release with no issues documented that would contribute to this complaint condition.Conclusion: a definitive root cause for complaint condition could not be determined from the provided information.However, it is possible that any unintended excessive forces could have contributed to broken portions followed by stuck complaint condition.No product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 europe reports an event in (b)(6) as follows: it was reported that the sagittal split ramus osteotomy (ssro) was performed on (b)(6) 2018 using the reported devices.It was reported that the drill tip could not come off the cannula when drilling.The surgery was completed successfully by using alternative device.There was no surgical delay and there was no adverse consequence to the patient.Patient outcome is reported as fine.This report is for one (1) matrixmandible 1.5mm drill bit j-latch for 03.503.045/.047.(b)(4).
 
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Brand Name
MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047
Type of Device
DRILL, BONE, POWERED
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7861217
MDR Text Key119958128
Report Number8030965-2018-56198
Device Sequence Number1
Product Code DZI
UDI-Device Identifier0761181997317
UDI-Public(01)0761181997317
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K043310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.503.476
Device Lot NumberU287574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2018
Initial Date FDA Received09/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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