MAUDE Adverse Event Report: SYNTHES (USA) 3.2MM DRILL BIT/QC/145MM; BIT, DRILL

Catalog Number 310.310

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 08/20/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the tip of a drill bit broke/snapped during use.The broken tip remained in the proximal femur as the surgeon could not retrieve the tip.Procedure was delayed by 40 minutes.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional common device name: hsz.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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 Description

The procedure being performed at the time this incident occurred was a femoral osteotomy in the subtrocanteric region of the femur to correct the rotation of the femur.This is done by making multiple drill holes at the same height in the femur and then passing an osteotome through the femur to join the holes together.During the second drill hole the drill tip snapped.Attempts were made to retrieve the tip but were unsuccessful.The procedure was completed by finding an alternative.

• Brand Name: 3.2MM DRILL BIT/QC/145MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4095545
• MDR Text Key: 16180272
• Report Number: 2520274-2014-13695
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK962913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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