MAUDE Adverse Event Report: SYNTHES BETTLACH 2.0MM DRILL BIT WITH 16MM STOP QC; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Catalog Number	03.617.916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.(b)(6).Device history records review was completed for part# 03.617.916, lot# 2608766.Manufacturing location: (b)(4), manufacturing date: jun 11, 2010.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 (b)(4) reports an event in (b)(6) as follow: it was reported on (b)(6) 2016, reported devices broke during the initial surgery.No delay to surgery time was reported.Surgery was completed successfully.Patient outcome was reported as good.This report is for one (1) drill bit.This is report 1 of 2 for com-(b)(4).
Additional Manufacturer Narrative
A product investigation was completed: the visual inspection of the returned drill bit has shown that approximately 10 mm from the fluted tip section is broken off.The broken off portion was not returned.Because of the damage the complaint relevant dimensions cannot be checked to print specifications anymore.The manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The used material was stainless steel 440a per standards as required and the measured harness was within the specification.The broken surface is homogenous what indicates material conformity as well.Based on the provided information we are not able to determine the exact cause of this complaint.It is likely that a mechanical overloading situation, for example metallic contact or lateral stress, has caused the breakage.No indication for product related issue was found.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: 2.0MM DRILL BIT WITH 16MM STOP QC
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6171567
• Report Number: 9612488-2016-10504
• Device Sequence Number: 16305087
• Product Code: OVE
• UDI-Device Identifier: 07611819933170
• UDI-Public: (01)07611819933170(10)2608766
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093762
• 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): 11/21/2016

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: 03.617.916
• Device Lot Number: 2608766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1