MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD SWITCHCUT REAMER 4.5 X 10.0MM W/ NITINOL PASSERS

Model Number	110027682
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Switch cut was reamed on to grade from lateral cortex of femur in to femoral notch.Reversed remer to retrograde reamer femoral socket and the switch cut blade caught at the top of the notch and broke off * 3 times.

• Brand Name: SWITCHCUT REAMER 4.5 X 10.0MM W/ NITINOL PASSERS
• Common Device Name: SWITCHCUT REAMER 4.5 X 10.0MM W/ NITINOL PASSERS
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• MDR Report Key: 6967648
• Report Number: 8043971-2017-00002
• Device Sequence Number: 18994923
• Product Code: HTO
• UDI-Device Identifier: 10810190013899
• UDI-Public: 10810190013899
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2017

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: Physician
• Device Expiration Date: 02/01/2021
• Device Model Number: 110027682
• Device Catalogue Number: 110027682
• Device Lot Number: 16K06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 102