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	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported that the patient received heat burns on their cheek.The twist drill was being used at 30,000 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.".
Additional Manufacturer Narrative
An investigation was performed in the lab.The review of the device revealed no breakage and only surface damage.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being identified.The investigation results conclude that the most likely root cause was due to an increased speed [rpm] of the drill.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: TWIST DRILL
• Common Device Name: TWIST DRILL
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8332125
• Report Number: 9610905-2019-00037
• Device Sequence Number: 53621
• Product Code: HTW
• UDI-Device Identifier: 00888118041548
• UDI-Public: (01)00888118041548
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/30/2019
• Report Date (Section F): 01/30/2019

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: Health Professional
• Device Model Number: 25-473-70-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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
• Patient Age: 27 YR