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

Model Number	71674077
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a tibial nail procedure the reducer broke while putting into patient's canal.A delay of less than 30 min was reported.A s&n back up was available to complete the procedure.No other complications were reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is broken into multiple pieces , rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that per complaint details, the device broke during use in the patients canal during a tibial nail procedure.Per correspondence, no foreign body was retained, no patient injury resulted, and the ¿surgery was considered a success¿ with the use of a backup device.It was communicated that there was a 0-30 minute surgical delay; however, the other requested documentation was not available.Based on the information provided, the patient impact beyond the modified surgical procedure and the reported 0-30 minute surgical extension could not be definitively concluded; however, since the ¿surgery was considered a success¿ further patient impact is not anticipated.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have 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 prolonged use, misuse or rough handling are 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 future complaints and investigate as necessary.Additional information: d3 and d8/d9.

• Brand Name: REDUCER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10910942
• Report Number: 1020279-2020-06763
• Device Sequence Number: 3419426
• Product Code: HSB
• UDI-Device Identifier: 03596010560735
• UDI-Public: 03596010560735
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: 71674077
• Device Catalogue Number: 71674077
• Device Lot Number: 06EMA0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 10/22/2021
• 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: Required Intervention