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

Model Number	71674523
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a trauma procedure, it was noticed that the following instruments of the trigen¿ intertan¿ instrument set are warped due to wear and tear over past 3 years: lag screw drill sleeve ((b)(4)), intertan 3.2mm guiide pin sleeve ((b)(4)), lag screw tap ((b)(4)), lag screw driver ((b)(4)), compression screw hexdriver ((b)(4)), subtroc lag screw driver ((b)(4)), 130 rad drill gde drop ((b)(4)), unknown trigen instrument ((b)(4)), unknown trigen instrument ((b)(4)).The procedure was able to be completed with the same device.Surgery was greater than 30mins delayed.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has signs of wear, tear and signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 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 DRILL SLEEVE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11853757
• Report Number: 1020279-2021-04511
• Device Sequence Number: 11766380
• Product Code: HSB
• UDI-Device Identifier: 00885556363249
• UDI-Public: 00885556363249
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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 Model Number: 71674523
• Device Catalogue Number: 71674523
• Device Lot Number: 15BCT0013
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1