MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD 7MM VERSITOMIC ISI BIOSTEON TAP

Model Number	TG118007ST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
Flexible 7mm tap broke off into patient as surgeon started to unscrew it after tapping the 28mm line.

• Brand Name: 7MM VERSITOMIC ISI BIOSTEON TAP
• Common Device Name: 7MM VERSITOMIC ISI BIOSTEON TAP
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• MDR Report Key: 7182018
• Report Number: 8043971-2017-00006
• Device Sequence Number: 1951934
• Product Code: HWK
• UDI-Device Identifier: 10810190016258
• UDI-Public: 10810190016258
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/07/2017

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 Model Number: TG118007ST
• Device Catalogue Number: TG118007ST
• Device Lot Number: 14E01
• 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: 12/07/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1