MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN SURESHOT DISTAL TARGETING SYST INSTR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported in the publication "orthopaedic surgery 2020.Reduced surgical time and higher accuracy of distal locking with the electromagnetic targeting system in humeral shaft intramedullary nailing".In this study there were 60 patients bearing s&n trigen nail implant.It was reported that, there was a patient with failure of distal locking, subsequent conversion to free hand fluoroscopy.

Manufacturer Narrative

Investigation results: the device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data provided is from a chinese article, ¿orthopedic surgery 2020.Reduced surgical time and higher accuracy of distal locking with the electromagnetic targeting system in humeral shaft intramedullary nailing".The provided translation was presented in excel spreadsheet in english.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.However, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN TRIGEN SURESHOT DISTAL TARGETING SYST INSTR
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10722318
• MDR Text Key: 212603009
• Report Number: 1020279-2020-05685
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other