MAUDE Adverse Event Report: SYNTHES SELZACH 3.2MM THREE-FLUTED RADIOLUCENTDRILL BIT/NEEDLE POINT/145MM; BIT, DRILL

Catalog Number 03.010.100

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2014

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that due to abrasion of the radiolucent drive bush, material was coated on the drill bit device.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper handling.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 2 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, while drilling, it was observed that black powdery substance started dropping from the connecting part of the radiolucent drive device.According to the report, the surgeon then stopped drilling and tried to extract the drill bit from the radiolucent drive device; however, it did not come off.Subsequently, after the operation, the drill bit was finally removed; and the connecting part of the radiolucent drive device became black.There were no delays in the surgical procedure as a spare device was available for use.It was reported that there was no harm to the patient.Therefore, there were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.2MM THREE-FLUTED RADIOLUCENTDRILL BIT/NEEDLE POINT/145MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4361717
• MDR Text Key: 13079970
• Report Number: 3000270450-2014-10179
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.100
• Device Lot Number: U174044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RADIOLUCENT-DRIVE DEVICE