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	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during surgery, reducer device broke where it screws together.The device broke during surgery, while inside the patient.It is unknown if pieces fell into the patient.The procedure was completed without delay using a smith & nephew back-up device.No other complications were reported.
Additional Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that without the requested clinical information or the device, the root cause of the reported failure cannot be determined.The retained device is non-implantable; therefore, long-term exposure with skin or tissue (implantation) data is not available.The patient impact beyond the reported device breakage/retained foreign body during the procedure could not be definitively determined.Although unlikely, the potential for corrosion and local irritation/migration of the fragment could not be ruled out.No further medical assessment can be rendered at this time.Should additional clinical documentation become available this complaint would be re-assessed.Approved by (b)(6) md on (b)(6) 2021.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: REDUCER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11283630
• Report Number: 1020279-2021-00977
• Device Sequence Number: 14323156
• Product Code: HSB
• UDI-Device Identifier: 03596010560735
• UDI-Public: 03596010560735
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71674077
• Device Catalogue Number: 71674077
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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