MAUDE Adverse Event Report: SYNTHES MONUMENT 12.0MM CANNULATED DRILL BIT LARGE QC/190MM; BIT, DRILL

Catalog Number	03.010.036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A device history record (dhr) review was performed on part # 03.010.036, lot # 38309: dhr review for part #03.010.036, lot #38309 could not be done because lot# is not available in docusphere.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
It was reported that on (b)(6) 2017, during an unknown surgery, while a surgeon was attempting to open the proximal tibia with the 12mm opening reamer; the 12mm cannulated drill bit broke where it was attached to the jacob's chuck.The broken piece was retrieved from the jacob's chuck and the surgeon used the 12mm awl to continue opening the proximal tibia.The surgery was delayed 10 minutes so the staff could find an alternative device to complete the surgery.The surgery was successfully completed with no additional medical intervention required.The broken drill bit will not be returned for investigation.Concomitant device reported: jacob's chuck (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12.0MM CANNULATED DRILL BIT LARGE QC/190MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6425519
• Report Number: 1719045-2017-10250
• Device Sequence Number: 310699
• Product Code: HTW
• UDI-Device Identifier: 10886982067098
• UDI-Public: (01)10886982067098(10)38309
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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: 03.010.036
• Device Lot Number: 38309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JACOB'S CHUCK (PART AND LOT # UNKNOWN, QTY 1)