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U.S. Department of Health and Human Services

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

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SYNTHES MONUMENT 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM REAMER Back to Search Results
Catalog Number 357.403
Device Problems Break; Tip
Event Date 12/09/2015
Event Type  Injury  
Manufacturer Narrative

(b)(6). Device is an instrument and is not implanted or explanted. The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Investigation could not be completed and no conclusion could be drawn as no device was returned. Device history record review: manufacturing date: july 30, 2008 - manufacturing site is synthes (b)(4). 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 this product that would contribute to this complaint condition. Device 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

It was reported that a patient underwent a left trochanteric fixation nail procedure secondary to a femur fracture. During the procedure, a portion of the tip of a stepped cannulated drill bit broke as the surgeon was drilling for lag screw insertion. The broken fragment was left in the patient. The surgeon continued to use the drill bit to complete drilling. The procedure was completed successfully with no reported delay. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

A product investigation was completed: the complaint condition for the 357. 403 lot number us93270 6. 0mm/10. 0mm stepped cannulated drill bit was likely caused by over seven years of consistent use and a possible collision with the nail or something harder than bone; however, this complaint is not likely a result of any design related deficiency. Per the technique guide, the 357. 403 6. 0mm/10. 0mm stepped cannulated drill bit is an instrument routinely used in the titanium trochanteric fixation nail system. The device was returned and reported that a piece of the tip broke off during surgery and was left in the patient. This condition is confirmed; one of the four distal prongs of the device has broken off leaving behind a rough fracture surface. It is likely that over seven years of consistent use and a possible collision with the nail or something harder than bone has led to this complaint condition. The device was manufactured in july 2008 and is over seven years old. The balance of the returned device is in fairly worn condition with dulled cutting edges. The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. The condition of the returned device does agree with the complaint description. Whether the complaint condition for this device can be replicated is not applicable for this condition. The risk assessment adequately addresses the complaint event. No non-conformance reports germane to the complaint condition were generated during the production of this device. 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.

 
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Brand Name6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5332611
Report Number1719045-2015-10860
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number357.403
Device LOT NumberUS93270
OTHER Device ID Number(01)10886982196262(10)US93270
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/13/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/30/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/29/2015 Patient Sequence Number: 1
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