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

Model Number 25-454-05-91

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

Lot numbers identified: 33312810 & 33521988.

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: 18317863
• MDR Text Key: 330374887
• Report Number: 9610905-2023-00067
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888118041050
• UDI-Public: (01)00888118041050
• 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: 11/13/2023

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
• Device Operator: Health Professional
• Device Model Number: 25-454-05-91
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/13/2023
• 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 Age: 11 YR
• Patient Sex: Female