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

Catalog Number 315.330

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reportedly there was no patient involvement.Device is an instrument and is not implanted/explanted.Contact phone number: (b)(6) manufacturing location: (b)(4).Manufacturing date: january 13, 2014.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 calibrated etch faded and the proximal coupling sheared off.The broken fragment was not retrieved.The pattern of the break indicates that the breakage was sudden.Relevant dimensions could not be measured due to post manufacturing damage.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 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 drill bit which reportedly did not fit with other parts.When the device was received, it was noted that the proximal coupling post 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
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6750076
• MDR Text Key: 81309935
• Report Number: 9612488-2017-10352
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982189295
• UDI-Public: (01)10886982189295(10)8781855
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315.330
• Device Lot Number: 8781855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1