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

Model Number 25-472-75-07

Device Problems Use of Device Problem (1670); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00237.

Event Description

It was reported a patient was burned while using a twist drill and trocar.The twist drill was being used at 20,000 rmps.It is stated in ifu 90-274-92-40 "twist drills are not designed to be used at speeds in excess of 5000 rpm.".

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.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 ifu indicates that drills are not to be used with than 5000 rmp.The provided information reveal that the root cause was an incorrect use by the customer.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
• Type of Device: TWIST DRILL
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 7919303
• MDR Text Key: 122073821
• Report Number: 9610905-2018-00236
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888118041432
• UDI-Public: (01)00888118041432
• 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,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-472-75-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2018
• Date Manufacturer Received: 12/18/2018
• 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
• Patient Age: 25 YR