MAUDE Adverse Event Report: SYNTHES MONUMENT 13.0MM FLEXIBLE CANNULATED DRILL BIT LARGE QC/465MM; BIT, DRILL

Catalog Number 03.010.034

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows it is reported that after opening the femur and drilling, surgeon tried to remove the drill.The drill bit broke at the shaft, shortly before it was out (approximately 1cm out of femur).Difficult to get out broken drill bit.The surgery was delayed for approximately 45 minutes to 60 minutes.No patient specific data was provided by the reporter.Only 2 pictures and drill bit are available.Patient seems to be young.The exact event date was not available but it is (b)(6) january 2014.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The exact event date was not available but it is (b)(6) 2014.The device is an instrument; cannot be implanted or explanted.The review of device history records has been requested.The investigation could not be completed and no conclusion could be drawn as the device is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Patient age is unknown, but reported as seeming young.A review of the device history records was completed: supplier lot # 15946-01.The certificate of compliance indicated the lot was manufactured to the relevant drawing and indicated the lot conformed to specifications.The 40-part lot was inspected and conformed to the synthes incoming final inspection sheet.There were no material review reports, non-conformance reports, or complaint-related issues with this lot.A manufacturing evaluation was completed: due to an unknown cause, the drive shaft broke near the 13mm, 3-fluted drill tip.The drive shaft (component p/n 03.010.034.2) exhibits numerous scratch and scuff marks.The lot initially conformed to specifications as noted in the certificate of compliance and the synthes incoming final inspection sheet.This complaint is confirmed, however, it is not supplier-caused.The lot was manufactured to the relevant synthes drawing.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.

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

An image reading of the x-rays was conducted by a medical director from this manufacturer and reported the following: "it is clear from the event description that there was a significant surgical delay while the broken drill bit was being removed - but it was removed so there is no evidence of this event to be seen on the x-rays.".

• Brand Name: 13.0MM FLEXIBLE CANNULATED DRILL BIT LARGE QC/465MM
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3676868
• MDR Text Key: 17389059
• Report Number: 1719045-2014-10060
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2014

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: 03.010.034
• Device Lot Number: 15946-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 03/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/09/2014; 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2008
• 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