MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN SCREWDRIVER 6.5; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	110120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, placing a 6, 5 mm cannulated screw, the surgeon noticed that the black handle was not fixed to the screwdriver shaft ¿ the screwdriver was not rotated when the handle was rotated.They could not proceed the surgery as planned.They had a backup 3, 5 hex screwdriver that was not cannulated.Drilled over the pin, took out the pin and placed the cannulated 6, 5 mm screw without the guidepin.There was a delay between 0-30 min during surgery.No patient injury or death.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2017 and exhibits signs of significant wear / usage.The functional evaluation confirmed the stated failure mode.The shaft turns inside the handle when force is applied.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.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.

• Brand Name: CANN SCREWDRIVER 6.5
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9318696
• Report Number: 1020279-2019-04037
• Device Sequence Number: 2373936
• Product Code: HSB
• UDI-Device Identifier: 03596010033970
• UDI-Public: 03596010033970
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K122170
• 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
• Report Date (Section B): 11/25/2019

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: 110120
• Device Lot Number: 17CM22675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1