MAUDE Adverse Event Report: TORNIER INC TORNIER EXTRACTION 12.5MM STRAIGHT OSTEOTOME

Model Number	ARS744400
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the osteotome broke during surgery.There is insufficient information regarding debris left in the patient from breakage of the instrument.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was returned and found to be in the condition stated in the event description.Based on investigation, the root cause was attributed to a wear related issue.The failure was caused by wear.The device is reusable, and the handle is made of plastic.It undergoes numerous cleaning and sterilization cycles.The combination of repetitive cleaning and use cause the device to fatigue which leads to the breakage noted in this complaint.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.

• Brand Name: TORNIER EXTRACTION 12.5MM STRAIGHT OSTEOTOME
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15833985
• Report Number: 0001649390-2022-00104
• Device Sequence Number: 17499593
• Product Code: HWM
• UDI-Device Identifier: 00846832089772
• UDI-Public: 00846832089772
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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: ARS744400
• Device Catalogue Number: ARS744400
• Device Lot Number: BH70166310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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 Sex: Unknown