MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META ANTERIOR DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71654501
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device get damaged during surgery.There was no affectation to the patient.
Additional Manufacturer Narrative
The meta anterior drop was returned and evaluated.A visual inspection could not identify any material deformation or damage that could cause the device to fail.Likewise, a functional examination found that all critical features worked as intended.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.The complaint history revealed no additional complaints for the associated batch.Additionally, a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; 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: META ANTERIOR DROP
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7854842
• Report Number: 1020279-2018-01742
• Device Sequence Number: 16478355
• Product Code: HSB
• UDI-Device Identifier: 03596010585820
• UDI-Public: 03596010585820
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• 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
• Report Date (Section B): 10/05/2018

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: 71654501
• Device Lot Number: 07KSP0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1