MAUDE Adverse Event Report: SYNTHES MONUMENT DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC; BIT, DRILL

Catalog Number	03.010.228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device history records review was completed for part# 03.010.228, lot# 6032305.Manufactured by: (b)(4), release to warehouse date: oct 10, 2008.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 investigation could not be completed; no conclusion could be drawn, as no product was received.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 follow: it was reported that during surgery on (b)(6) 2017, the drill bit broke.No delay in surgery was reported.No information available about patient condition and outcome.This report is for one (1) drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6442714
• Report Number: 1719045-2017-10271
• Device Sequence Number: 16251545
• Product Code: HTW
• UDI-Device Identifier: 07611819307711
• UDI-Public: (01)07611819307711(10)6032305
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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: Physician
• Device Catalogue Number: 03.010.228
• Device Lot Number: 6032305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1