MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD SWITCHCUT REAMER 4.5 X 9.5MM W/ NITINOL PASSERS

Model Number	110027681
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an initial surgery on an unknown date due to osteolysis.Subsequently, the patient was revised due to unknown reason on (b)(6) 2016.The cutting wing on the reamer broke off while reaming the femoral tunnel.The reamer was no longer functional.Surgeon removed the broken piece from the joint.New reamer was opened and the surgery was completed.

• Brand Name: SWITCHCUT REAMER 4.5 X 9.5MM W/ NITINOL PASSERS
• Common Device Name: SWITCHCUT REAMER 4.5 X 9.5MM W/ NITINOL PASSERS
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• MDR Report Key: 7156478
• Report Number: 8043971-2018-00001
• Device Sequence Number: 1786163
• Product Code: HTO
• UDI-Device Identifier: 10810190013882
• UDI-Public: 10810190013882
• 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
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2017

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: 01/01/2020
• Device Model Number: 110027681
• Device Catalogue Number: 110027681
• Device Lot Number: 15F05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2018
• 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