MAUDE Adverse Event Report: SYNTHES MONUMENT 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM; REAMER

Catalog Number	357.403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient information was not available for reporting.Implant and explant dates: device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.The results of the investigation are pending completion.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date(s) of manufacture/release to warehouse date(s): jan 19, 2004, feb 2, 2004, and feb 27, 2004.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 the synthes 6.0mm / 10.0mm stepped cannulated drill bit broke during a trochanteric fixation nail (tfn) procedure on (b)(6) 2016.There were no fragments retained in the patient and the surgery was completed successfully without any delay.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product investigation was completed for part #357.403, lot #um28415.A visual inspection, drawing review and device history records review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.The proximal tip was confirmed to be broken.The device has surface wear which does not impact functionality.No other issues observed.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.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: 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6255251
• Report Number: 1719045-2017-10025
• Device Sequence Number: 18945643
• Product Code: HTO
• UDI-Device Identifier: 10886982196262
• UDI-Public: (01)10886982196262(10)UM28415
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 12/26/2016

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: 357.403
• Device Lot Number: UM28415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1