MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SINGLE RIKKI RETRACTOR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71934609
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the retractor did bent rather than elevated the bone.Delay of less than 30 minutes reported.The procedure was completed using a competitor device.There was no impact to the patient.The final outcome was successfully.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned single rikki retractor confirms the device is bent.This device was manufactured in 2018.This device exhibits signs of significant wear and usage.A material analysis was conducted and we were able to verify that the product met the size requirement for thickness and width however it did not meet the hardness specifications.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.Based on this investigation, corrective and preventive action is indicated to mitigate future recurrence of similar events.Should additional information be received, the complaint will be reopened.

• Brand Name: SINGLE RIKKI RETRACTOR
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; smith & nephew, inc.; memphis TN 38116
• Manufacturer Contact: sarah freestone ; smith & nephew, inc.; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 8670697
• Report Number: 1020279-2019-02193
• Device Sequence Number: 16665777
• Product Code: HSB
• UDI-Device Identifier: 00885556208847
• UDI-Public: 00885556208847
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2022

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: 71934609
• Device Catalogue Number: 71934609
• Device Lot Number: 18FM21215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 01/29/2020; 09/28/2022
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 02/03/2020; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2818-2020
• Patient Sequence Number: 1
• Patient Sex: Unknown