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

Model Number 25-473-70-07

Device Problems Temperature Problem (3022); Device Handling Problem (3265)

Patient Problem Burn(s) (1757)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The root cause the root cause for this event was determined to be an incorrect use of the device.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Additional product for this event and patient captured in mdr 9610905-2018-00007.

Event Description

It was reported that the patient received heat burns bilaterally on their cheeks.The twist drill was being used at 35,000 rpm with a trocar.It is stated in ifu 90-274-92-40 and 91-600-00-41 under precautions "when using twist drills, copious amounts of irrigation are mandatory to alleviate excessive heat generation, which can lead to bone necrosis, and in extreme cases, soft tissue burns through contact with trocar and cannula." and "twist drills are not designed to be used at speeds in excess of 5000 rpm." the burnt tissue was cut out like a scar revision.

• Brand Name: TWIST DRILL
• Type of Device: TWIST DRILL
• 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: 7272819
• MDR Text Key: 100142390
• Report Number: 9610905-2018-00006
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888118041548
• UDI-Public: (01)00888118041548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLS 1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2018,01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 25-473-70-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2018
• Date Manufacturer Received: 01/17/2018
• 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