MAUDE Adverse Event Report: SYNTHES MONUMENT MATRIXMANDIBLE 1.5MM DRILL BIT MQC W/12MM STOP/50MM; DRILL, BONE, POWERED

Catalog Number	03.503.512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement.Date of device breakage is not known.Device is an instrument and is not implanted/explanted.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.Dhr review for part #03.503.512, synthes lot# u114794.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: 12-jan-2010, 26-jan-2010, 09-feb-2010, 04-mar-2010, 18-mar-2010, 02-apr-2014 supplier: (b)(6).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 europe reports an event in (b)(6) as follows: it is reported the drill bit with stop was received broken.No patient or surgical involvement.This report is for one (1) drill bit with stop.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
Additional Manufacturer Narrative
The visual inspection of the returned drill bit has shown that approximately 9 mm from the fluted tip section is broken off.The broken tip was not returned for evaluation.Additionally there are a lot of wear marks and scratches at the whole instrument visible.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the products that would contribute to this complaint condition.These parts were manufactured at a supplier.The incoming inspection after the manufacturing of the products has shown no deviations or non-conformances.The parts were measured and the review of the dhr review has shown that the correct material was used.Measurement outer diameter ø1.5: result: ø1.5 "pass" dhr review, no findings chu evaluation, no findings.Based on these findings we exclude any manufacturing related issue.Based on the provided information we are not able to determine the exact cause which has led to this breakage.We only can assume that a mechanical overloading situation, for example metallic contact or lateral stress, has caused the breakage.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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.

• Brand Name: MATRIXMANDIBLE 1.5MM DRILL BIT MQC W/12MM STOP/50MM
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6540741
• Report Number: 1719045-2017-10399
• Device Sequence Number: 133915
• Product Code: DZI
• UDI-Device Identifier: 07611819383043
• UDI-Public: (01)07611819383043(10)U114794
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/07/2017

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: 03.503.512
• Device Lot Number: U114794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 10/17/2017; 10/17/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 06/15/2017; 06/26/2017; 10/17/2017; 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1