MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 32CM; NAIL, FIXATION, BONE

Model Number	71655132
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the day after surgery of intramedullary 10×320 nailing trigen meta-nail, the patient was taken to emergency due to persistent oedema and progressive hypoesthesia with dorsiflexion¿s impairment.(cta) revealed the presence of a psa and avf.Endovascular approach under local anesthesia.
Additional Manufacturer Narrative
Results of investigation: it was reported that the day after surgery of intramedullary 10×320 nailing trigen meta-nail, the patient was taken to emergency due to persistent oedema and progressive hypoesthesia with dorsiflexion¿s impairment.The associated device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device details were not made available, device history record review cannot be completed.Complaint history review revealed no prior complaints for the listed failure mode.A relationship, if any, between the device and the reported incident could not be corroborated.There is no information that would suggest the device failed to meet specifications.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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.
Additional Manufacturer Narrative
Updated results of investigation: it was reported that the day after surgery of intramedullary 10×320 nailing trigen meta-nail, the patient was taken to emergency due to persistent oedema and progressive hypoesthesia with dorsiflexion¿s impairment.The associated device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device details were not made available, device history record review cannot be completed.Complaint history review revealed no prior complaints for the listed failure mode.A relationship, if any, between the device and the reported incident could not be corroborated.There is no information that would suggest the device failed to meet specifications.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Probable causes could include but not limited to patient medical history or patient reaction.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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-NAIL TIBIAL 10MM X 32CM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8921411
• Report Number: 1020279-2019-03130
• Device Sequence Number: 1903624
• Product Code: JDS
• UDI-Device Identifier: 03596010585554
• UDI-Public: 03596010585554
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2020

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: 71655132
• Device Catalogue Number: 71655132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019; 07/25/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 01/17/2020; 02/19/2020
• 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; Required Intervention