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

Model Number	71674087
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a trauma surgery while the instruments were inside of the patient, the lag driver retaining rod assay capture stick caught onto a guide pin and seemed to be defective; the piece on the trigen t-handle was broken in the captures of the screwdriver.There were no pieces broken off inside of the patient.The procedure was successfully completed with no significant delay using a smith and nephew back up device.Patient was not harmed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a trauma surgery while the instruments were inside of the patient, the lag screw driver (b)(4) capture stick caught onto a guide pin and seemed to be defective; the piece on the t-handle (b)(4) was broken in the captures of the screwdriver.There were no pieces broken off inside of the patient.The procedure was successfully completed with no significant delay using a smith and nephew back up device.Patient was not harmed.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned lag screw driver confirmed the inner part that connects to the mating device is damaged on the tip.This device also has extensive wear usage.A review of complaint history on the listed part revealed no additional complaints for the listed batch with the same failure mode a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of this complaint case revealed there were no patient injuries reported.Per e-mail communication, no pieces broken off inside of the patient and the procedure was completed with a backup device.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.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.We consider this investigation closed.

• Brand Name: LAG SCREW DRIVER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11909918
• Report Number: 1020279-2021-04873
• Device Sequence Number: 4395362
• Product Code: HSB
• UDI-Device Identifier: 03596010580443
• UDI-Public: 03596010580443
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71674087
• Device Catalogue Number: 71674067
• Device Lot Number: 08LCT0019
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 08/03/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 06/24/2021; 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention