MAUDE Adverse Event Report: SYNTHES BETTLACH 3.2MM THREE-FLUTED DRILL BIT QC/210MM/68MM CALIBRATION; BIT, DRILL

Catalog Number	315.330
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Date of event: unknown.Device is an instrument and is not implanted/explanted.Manufacturing location: (b)(4).Manufacturing date: october 17, 2012.No non-conformance reports were generated during production.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.A product investigation was completed: a visual inspection under 5x magnification, functional test, drawing review, and dimensional analysis were performed as part of this investigation.A definitive root cause cannot be identified with the limited complaint details.No new, unique or different patient harms were identified as a result of this evaluation.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.The device was returned with the distal tip broken off.This fragment was not returned.The cutting flutes were also worn down below specification.This drill bit is a single use item.Based on the condition and the age of the returned part, it is unlikely that design contributed to the complaint condition.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 was reported that parts were detected as damaged during internal inspection of loaner kits.Reportedly there was no patient or procedure involvement.This report is for a drill bit which reportedly was damaged.When the device was received, it was noted that the distal tip was broken; the broken portion was not received.This report is for (b)(4).

• Brand Name: 3.2MM THREE-FLUTED DRILL BIT QC/210MM/68MM CALIBRATION
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6751752
• Report Number: 9612488-2017-10371
• Device Sequence Number: 881389
• Product Code: HTW
• UDI-Device Identifier: 10886982189295
• UDI-Public: (01)10886982189295(10)8108821
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/30/2015

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: 315.330
• Device Lot Number: 8108821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1