MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MM; BIT DRILL

Catalog Number	03.503.408
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 at the time of filing this report.A review of the device history record has been requested.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a msx fax consultant, (b)(6) from (b)(4) had an issue with the trans-buccal drill bits.None of the drill bits would cut and one.Radiology had to check and confirm that they had not left it in the patient.Attached is a photo of the drill bits that were used and would not cut and with tips blackened.Eventually, a standard intra-oral drill bit did cut.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).
Additional 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.H3, h4, h6: a review of the device history record.Device history lot.Manufacturing location: orchid unique / inspected, packaged and released by: monument.Release to warehouse date(s): 12-dec-2017 quantity 147 / 13-mar-2018 quantity 349 / 21-feb-2018 quantity 45.Part number: 03.503.408, matrixmandible 1.5mm drill bit j-latch w/8mm stop/50mm lot number: u288831 (non-sterile) lot quantity: 541 total (three batches) purchased finished goods travelers met all inspection acceptance criteria.Inspection sheets, incoming final inspection rev g met all inspection acceptance criteria.Certificates of conformance received from orchid dated 30-nov-2017 were reviewed and determined to be conforming.Heat treat specified were reviewed and determined to be conforming.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 16-jan-2020: dhr reviewed.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, could not be confirmed based on the provided picture.Investigation site: cq zuchwil, selected flow: functional / damage.Visual inspection: six drill bits were returned for evaluation with the reported condition of not functioning.Visual inspection confirmed that the drill bits are badly damaged, the cutting edges are quite blunt and rounded, some of the tips are blackened and melted down.Some drill bits are bent.In general, the instruments are in very used condition.But none of the returned items is broken.Summary the complaint condition is confirmed as the tips of the drill bits are either dull/blunt or deformed.The review of the production history revealed that this production lot (lot# u288831) was manufactured in december 2017 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.After a visual inspection per guidance it is determined that the reusable instrument (part# 03.503.408) is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Further information / precaution hints can be found in the respective surgical technique for the matrixmandible system; special attention should be made to the precaution: ¿ drill speed rate should never exceed 1,800 rpm, particularly in dense, hard bone, - avoid damaging the plate threads with the drill, - always irrigate during drilling to avoid thermal damage to the bone.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.(photos available) 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 or Problem Description
Update: this report is 1 of 6 for (b)(4).

• Brand Name: MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MM
• Common Device Name: BIT DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9604480
• Report Number: 8030965-2020-00460
• Device Sequence Number: 2721544
• Product Code: DZI
• UDI-Device Identifier: 07611819975231
• UDI-Public: (01)07611819975231
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.503.408
• Device Lot Number: U288831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1