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

Model Number	25-473-70-07
Medical Device Problem Codes	Temperature Problem (3022); Device Handling Problem (3265)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional 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.Reference exemption number e2017029.
Event or Problem 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
• Common Device Name: TWIST DRILL
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 7272819
• Report Number: 9610905-2018-00006
• Device Sequence Number: 16176885
• Product Code: HTW
• UDI-Device Identifier: 00888118041548
• UDI-Public: (01)00888118041548
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: CLS 1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2018
• Report Date (Section F): 02/15/2018

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?: No
• Operator of Device: Physician
• Device Model Number: 25-473-70-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/15/2018