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

Catalog Number 357.403

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.

• Brand Name: 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM
• Type of Device: REAMER
• 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 Key: 5332611
• MDR Text Key: 34601308
• Report Number: 1719045-2015-10860
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• 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 Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.403
• Device Lot Number: US93270
• Other Device ID Number: (01)10886982196262(10)US93270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR