MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 9MM X 40CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71649540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision nail surgery was performed due to a broken nail at the distal level dynamic screw.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.This case reports a revision surgery was performed due to a meta-tan nail broken at the distal level, orifice of the dynamic screw.The date of implantation was not provided; therefore, the length of time in situ is unknown.It was reported the surgery was performed to remove the broken product and implant another.However, no clinically relevant information has been provided after three requests.Two pre-revision x-rays, undated, were provided that confirm the broken nail as well as a persistent non-union of the femur fracture site.All documents and images provided as of this date have been reviewed and considered and, unless noted, do not contribute to the clinical investigation.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.A review of complaint history did not reveal any prior complaints for the listed batch.Without the explant and/or the requested clinical information, the root cause of the nail breakage cannot be determined.The further impact the patient beyond the revision cannot be concluded.No further clinical/medical investigation is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.If the device or new information is received in the future, this complaint can be re-opened.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: META-TAN 9MM X 40CM LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6856004
• Report Number: 1020279-2017-00729
• Device Sequence Number: 13618111
• Product Code: HSB
• UDI-Device Identifier: 00885556338698
• UDI-Public: 00885556338698
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2018

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 Expiration Date: 11/02/2025
• Device Catalogue Number: 71649540
• Device Lot Number: 15LM04279
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 04/16/2018
• 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: Hospitalization; Other; Required Intervention