MAUDE Adverse Event Report: SYNTHES (USA) 5.0MM/7.3MM STEPPED DRILL BIT 20MM STEP FOR SCFE SCREW; DRILL, BIT

Catalog Number 03.207.008

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 07/03/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).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.

Event Description

It was reported that a drill bit broke during surgery.The procedure was completed successfully.The surgery was delayed 30 to 45 minutes due to the reported event.Additional information was requested but was not made available.This report is 1 of 1 for (b)(4).

• Brand Name: 5.0MM/7.3MM STEPPED DRILL BIT 20MM STEP FOR SCFE SCREW
• Type of Device: DRILL, BIT
• 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: 5013531
• MDR Text Key: 23424498
• Report Number: 2520274-2015-15302
• Device Sequence Number: 1
• Product Code: HTW
• 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: Nurse
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.207.008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• 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
• Patient Age: 13 YR