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 Patient Involvement (2645)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frame stabilizer tool is locked.As noticed upon inspection, no case was involved.
Additional Manufacturer Narrative
The devices, intended for use in treatment, were returned for evaluation.A visual inspection of the returned devices confirm the hex nuts are seized in place causing the stated failure.These devices were manufactured in 2015.These devices exhibit signs of wear and usage.A review of complaint history on the listed part revealed prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.These devices are reusable instruments 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.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 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: 10167100
• Report Number: 1020279-2020-02495
• Device Sequence Number: 2102065
• Product Code: KTT
• UDI-Device Identifier: 00885556119358
• UDI-Public: 00885556119358
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 71070343
• Device Catalogue Number: 71070343
• Device Lot Number: 15DM00959
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1