MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACHIEVECAS STANDARD POSITIONER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	74471201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the pommel of the impactor sheared off.Device did not break in patient.Delay of over 30 min reported.No injury reported.No back up available, had to abort nav and use old offset impactor.
Additional Manufacturer Narrative
The affected achievecas standard positioner was returned and evaluated.A visual inspection of the returned device confirmed the failure mode as the weld has fractured at the strike plate.The broken piece is returned.The device was manufactured in 2005 and it exhibits signs of significant wear/usage.If sufficient impact forces placed upon the instrument are transferred through the welded area, fracture may occur in the welded area due to a static or fatigue failure mechanism.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: ACHIEVECAS STANDARD POSITIONER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8269014
• Report Number: 1020279-2019-00245
• Device Sequence Number: 2082255
• Product Code: HAW
• UDI-Device Identifier: 03596010513960
• UDI-Public: 03596010513960
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033341
• 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): 01/24/2019

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: 74471201
• Device Lot Number: 05BM14832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1