MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW DRILL SLEEVE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674023
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the sleeve does not close adequately.Neither the guide pin or the anti-rotation bar enter adequately and need to be forced to enter.More than 2 hours delay was reported and a backup device was available but not sterile.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned lag screw drill sleeve confirms there is extensive use and wear seen on the device.The device was manufactured in 2009.A functional evaluation was conducted with a mating device and confirms the lag screw drill sleeve will not allow mating device to enter smoothly.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LAG SCREW DRILL SLEEVE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9163288
• Report Number: 1020279-2019-03569
• Device Sequence Number: 16672365
• Product Code: HSB
• UDI-Device Identifier: 03596010560520
• UDI-Public: 03596010560520
• Combination Product (Y/N): N
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 71674023
• Device Lot Number: 09LCT0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1