MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FRAME STABILIZER TOOL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71070343
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a revision of a taylor spatial frame, the bolt on the bar clamp wouldn't sufficiently tighten.The revision was not as a result of the issue with the bolt.There was a change in surgical technique due to this malfunction, the surgeon used a connection plate and threaded rod to stabilize the frame.No delay reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical investigation concluded that after three requests, no relevant clinical information, operative report or the device were provided to determine a root cause of the reported issue.Per the report, the bolt on the bar clamp would not sufficiency tighten during the revision.However, the issue with the bolt was not the reason for the revision.Per communications, it was the surgeon¿s decision to change the surgical technique due to the malfunction, by using a connection plate and threaded rod to stabilize the frame.Since there was no reported delay, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant medical information be provided, this complaint will be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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: FRAME STABILIZER TOOL
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11371562
• Report Number: 1020279-2021-01552
• Device Sequence Number: 19771624
• Product Code: KTT
• UDI-Device Identifier: 00885556119358
• UDI-Public: 00885556119358
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• 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): 07/21/2021

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: 71070343
• Device Catalogue Number: 71070343
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: Other; Required Intervention