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

Model Number 25-452-00-91

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/24/2023

Event Type  Injury  

Manufacturer Narrative

An investigation was performed in the lab and 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.Review of the device history records was not possible due to no lot number being identified.The investigation results conclude that the root cause for this failure could not be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

Event Description

It was reported during initial surgery a twist drill broke during use.A portion of it remains implanted.

• Brand Name: LEVEL ONE
• 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): 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: 18317865
• MDR Text Key: 330375062
• Report Number: 9610905-2023-00066
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888118040954
• UDI-Public: (01)00888118040954
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLS 1 EXEMPT
• Exemption Number: 2017029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-452-00-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male