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

Model Number	71933931
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a small rail system was applied to a tibial non-union on (b)(6) 2020.There was two segments and three 6mm pins in each segment.After 12 days the rail broke.The patient received a revision surgery and device was exchanged to a large modular rail.No additional information provided.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Investigation results: it was reported that a small rail system was applied to a tibial non-union.There was two segments and three 6mm pins in each segment.After 12 days the rail broke.The patient received a revision surgery and device was exchanged to a large modular rail.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, a device history record review cannot be completed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.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 risk management files found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Potential causes of the reported event could include but not limited to improper size of device used, lifetime of device, overuse or procedural/use error.Without the return of the actual product involved and no device records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SMALL RAIL
• 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: 10844665
• Report Number: 1020279-2020-06486
• Device Sequence Number: 11712288
• Product Code: KTT
• UDI-Device Identifier: 00885556065334
• UDI-Public: 00885556065334
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 71933931
• Device Catalogue Number: 71933931
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6MM PIN UNKN P/N (6 UNITS); 6MM PIN UNKN P/N (6 UNITS)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention