MAUDE Adverse Event Report: FH INDUSTRIE TLS; TLS DRILL

Model Number	250101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
One of the instrument's fins broke while pivoting for removal.
Event or Problem Description
One of the instrument's fins broke while pivoting for removal.

• Brand Name: TLS
• Common Device Name: TLS DRILL
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: el yazid aribi ; 6 rue nobel; quimper 29000 ; FR 29000
• MDR Report Key: 14917512
• Report Number: 3003898228-2022-00009
• Device Sequence Number: 16636698
• Product Code: HWC
• UDI-Device Identifier: 03661489501012
• UDI-Public: 03661489501012
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 250101
• Device Lot Number: C90142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male