MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 10MM X 38CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71649638
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that meta tan left 10mm x 38 had to be exchanged due to non-union.No patient information was initially provided.
Additional Manufacturer Narrative
It was reported that meta tan left 10mm x 38 had to be exchanged due to non-union.No patient information was initially provided.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.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 and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation, therefore, no medical assessment can be performed at this time.Some potential causes of the reported event could include but are not limited to abnormal motion over time, abnormal loading of limb, friction or high impact on limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical 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: META-TAN 10MM X 38CM LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10850463
• Report Number: 1020279-2020-06533
• Device Sequence Number: 11670096
• Product Code: HSB
• UDI-Device Identifier: 00885556339749
• UDI-Public: 00885556339749
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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: Lay User/Patient
• Device Model Number: 71649638
• Device Catalogue Number: 71649638
• Device Lot Number: 18AM20498
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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: TRIGENLOWPROFILESCREW5.0MMX40MM/71645040/19AM11379; TRIGENLOWPROFILESCREW5.0MMX40MM/71645040/19DM01200; TRIGENLOWPROFILESCREW5.0MMX65MM/71645065/18KM04120; TRIGENLOWPROFILESCREW5.0MMX40MM/71645040/19AM11379; TRIGENLOWPROFILESCREW5.0MMX40MM/71645040/19DM01200; TRIGENLOWPROFILESCREW5.0MMX65MM/71645065/18KM04120
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention