MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONICAL TAP 7MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	09FSY0001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip broke off inside the femur.The tip could not be retrieved and so was left in situ in the patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based on the available, the root cause for the instrument breaking cannot be concluded.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.It is also unknown if this event will cause any future harm or problems for the patient.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: CONICAL TAP 7MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7426235
• Report Number: 1020279-2018-00754
• Device Sequence Number: 127862
• Product Code: MDM
• UDI-Device Identifier: 03596010437631
• UDI-Public: 03596010437631
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 09FSY0001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/03/2018; 04/03/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/28/2018; 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other