MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COVE PT PIN 120 X 28 X3MM STER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	74473200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during thr the pin sheered off during placement at junction of threads and shaft of pin.The threaded portion of the pin remains in patient at the anterior superior iliac spine.Delay of less than 30 min reported.A back up device was available.No procedure or medical intervention reported to retrieve the fragment.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured at the start of the first thread and only the shaft was returned.The device was manufactured in 2018.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: COVE PT PIN 120 X 28 X3MM STER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8651097
• Report Number: 1020279-2019-02086
• Device Sequence Number: 14262068
• Product Code: HAW
• UDI-Device Identifier: 00885556074527
• UDI-Public: 00885556074527
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012938
• 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): 06/19/2019

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: 74473200
• Device Lot Number: 18AM18957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 95