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

Model Number	25-449-16-91
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a twist drill broke during use.A portion remains implanted.
Additional Manufacturer Narrative
The reported rpms exceeded the maximum recommended speed found in the ifu.
Additional Manufacturer Narrative
An investigation was performed using a stereo microscope revealed tensile cracks.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.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.The reported rpms exceeded the maximum recommended speed found in the ifu.D4 lot number updated identified during investigation.

• Brand Name: LEVEL ONE
• Common Device Name: TWIST DRILL
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN L.P.; p.o. box 16369; jacksonville FL 32245
• Manufacturer Contact: melissa bachorski ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 16253282
• Report Number: 9610905-2022-00112
• Device Sequence Number: 14764829
• Product Code: HTW
• UDI-Device Identifier: 00888118040817
• UDI-Public: (01)00888118040817
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: CLS 1 EXEMPT
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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: 25-449-16-91
• Device Lot Number: 33493185
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Male