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

Catalog Number	71369007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 7mm conical tap instrument snapped at the distal tip (approx.2-3cm) during a revision hip surgery.Surgeon attempted to retrieve broken tip with various graspers.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.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.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned conical tap indicated that the distal end fractured off, confirming the stated complaint.This device was manufactured in 2009, showing damage from wear/use.A clinical analysis indicated that this case reports during a hip revision surgery, a 7mm tap snapped at distal tip (approx.2-3cm) was left in the patient¿s femur.The post-operative condition of the patient is unknown at this time.The broken tip of the non-implantable tip remains in the patient¿s femur and it is unknown whether micro-motion/migration could occur.Therefore, the future impact to the patient beyond the retained tip cannot be determined.No further clinical assessment is warranted based on the limited details provided.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.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: 7485983
• Report Number: 1020279-2018-00843
• Device Sequence Number: 2052843
• Product Code: MDM
• UDI-Device Identifier: 03596010437631
• UDI-Public: 03596010437631
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2019

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 Catalogue Number: 71369007
• Device Lot Number: 09FSY0001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018; 04/13/2018; 04/13/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 05/04/2018; 07/10/2018; 04/23/2019
• 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