MAUDE Adverse Event Report: SYNTHES USA 5.0MM CANNULATED DRILL BIT LARGE QC/300MM; BIT, DRILL

Catalog Number 310.63

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Sedation (2368); Device Embedded In Tissue or Plaque (3165)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It was reported that during a revision of slipped capital femoral epiphysis, a cannulated drill bit broke on impact with another screw while drilling over a pin.The screw was fine.Multiple attempts were made to remove the broken pieces and lots of x-rays were taken during this time.A small piece of the drill bit remained in the patient.The procedure was completed successfully and the patient outcome was reported as good.There was a report of a ninety minute surgical delay.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM CANNULATED DRILL BIT LARGE QC/300MM
• 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: 4012327
• MDR Text Key: 4775606
• Report Number: 2520274-2014-13165
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2014

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: 310.63
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 08/15/2014
• 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
• Patient Age: 14 YR