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

Catalog Number 310.63

Device Problem Smoking (1585)

Patient Problem Injury (2348)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.(b)(4) lot unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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.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

It was reported that the patient underwent a slipped capital femoral epiphysis on (b)(6) 2017.During the procedure the surgeon reported the drill bit was smoking while drilling into the patient¿s bone for placement of a 2.5mm cannulated screw, she also noted the drill bit was dull.Reportedly, another drill bit was used to successfully complete the procedure.It is unknown if this event resulted in a surgical delay.The patient outcome is unknown.It is unknown if the patient received treatment for the bone injury.Concomitant devices reported: drill (part/lot unknown, quantity 1).This is report 1 of 1 for( b)(4).

• Brand Name: 5.0MM CANNULATED DRILL BIT LARGE QC/300MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6743403
• MDR Text Key: 81004546
• Report Number: 1719045-2017-10696
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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
• Date Manufacturer Received: 06/29/2017
• 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
• Treatment: 1 UNKNOWN DRILL
• Patient Outcome(s): Required Intervention