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

Catalog Number	71152151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the inner sleeve of the lag screw removal wrench broke when removing the lag screw.Device's retaining rod had to be cut to remove the lag screw.No delay or injury reported.No back up device available was reported.
Event or Problem Description
It was reported that during surgery the inner sleeve of the lag screw removal wrench broke when removing the lag screw.Device's retaining rod had to be cut to remove the lag screw.A delay of 3 hours was reported.No injury reported.No back up device available was reported.
Additional Manufacturer Narrative
The associated lag screw removal wrench was not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Therefore, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.It was reported that the retaining rod had to be cut due to the centering sleeve which had fused to the lag screw, as the implant was in the patient for 20 years.The device was manufactured in 2014, which suggests it has been in use for some time.The lag screw removal wrench is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; and smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LAG SCREW REMOVAL WRENCH
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8384627
• Report Number: 1020279-2019-00888
• Device Sequence Number: 389912
• Product Code: HSB
• UDI-Device Identifier: 03596010519092
• UDI-Public: 03596010519092
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/17/2019

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: 71152151
• Device Lot Number: 14CCT0005
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019; 02/08/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 03/20/2019; 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1