MAUDE Adverse Event Report: SYNTHES MONUMENT MATRIXMANDIBLE 1.5MM DRILL BIT MQC/125MM F/03.503.045/047; DRILL, BONE, POWERED

Catalog Number	03.503.479
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.Hospital contact telephone: (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review for part #03.503.479, synthes lot#us94851 ncr us1008616 was generated for one part with gray paint on shaft of part above part number etch.This was determined to be an anomaly and part was scrapped.This non-conformance is not relevant to the complaint condition.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: 21-aug-2008, 25-may-2010, 13-jul-2010.Supplier: (b)(4).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 2 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
Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (matrixmandible 1.5mm drill bit mqc/125mm f/03.503.045/047, part number 03.503.479, lot number us94851).The subject device was returned with the complaint condition stating: the visual inspection of the returned drill bits has shown that approximately 25 mm from the fluted tip sections are broken off.The broken tips were not returned for evaluation.Additionally, there are a lot of wear marks and scratches at the whole instrument visible.The color marks are partially disappeared.Nonconformance was generated for one part with gray paint on shaft of part above part number etch.This was determined to be an anomaly and part was scrapped.This non-conformance is not relevant to the complaint condition.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.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.Further investigation has shown that these instruments were manufactured in august 2008.Measurement outer diameter ø1.5: gage: 3-03-17585; tolerance ø1.5 +0.01/-0.014; result of both drill bits are: ø1.5 "pass".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.As these parts are now more than 8 years old, we suppose that the damages were caused due to wear and tear over the years.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/125MM F/03.503.045/047
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6540954
• Report Number: 1719045-2017-10401
• Device Sequence Number: 75127
• Product Code: DZI
• UDI-Device Identifier: 07611819975279
• UDI-Public: (01)07611819975279(10)US94851
• 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
• 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: 03.503.479
• Device Lot Number: US94851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 06/15/2017; 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1