MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG TWIST DRILL; DRILL BIT

Model Number 25-469-11-07

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/14/2015

Event Type  Injury  

Event Description

The tip of the twist drill broke off while being used through a trocar.The broken tip was unable to be removed and remains in the patient's right mandible.No revisional surgery is scheduled to remove the twist drill tip.

Manufacturer Narrative

The actual device was not available for return; therefore no proper physical evaluation could be performed on the device.However, product history records were able to be reviewed based on the lot number provided and revealed no abnormalities.An investigation was also performed based on complaint statistics and determined the complaint percentage falls well within the product risk limits adhered to by the manufacturer.With no actual device to physically evaluate, the root cause for the breakage cannot be determined at this time.If further information is gathered that might add value to the content of this report, an additional follow-up report will be sent.

• Brand Name: TWIST DRILL
• Type of Device: DRILL BIT
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 5108259
• MDR Text Key: 26905634
• Report Number: 9610905-2015-00043
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 25-469-11-07
• Device Lot Number: K6D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR