MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW RETAINING ROD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71665036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during revision surgery (planned procedure), the lag screw rationing rod sheared while implanting a screw inside the patient, everything was recovered delay under 30 min.S+n back-up device available and used, no injury reported.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The threaded tip of the retaining rod on the driver fractured off inside the lag screw.All pieces were returned.The driver was manufactured in 2016 and exhibits signs of extensive wear usage.The lag screw was manufactured in 2015 and exhibits signs of attempted use.A review of complaint history did not reveal additional complaints for the listed batches.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.

• Brand Name: LAG SCREW RETAINING ROD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9227277
• Report Number: 1020279-2019-03719
• Device Sequence Number: 19364450
• Product Code: LXH
• UDI-Device Identifier: 00885556038079
• UDI-Public: 00885556038079
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 71665036
• Device Lot Number: 16JSP0001
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1