MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPATIAL FRAME STRUT EXT SHT; PIN, FIXATION, THREADED

Model Number 71070200

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, a spatial frame strut ext sht was reported as too big and bulky for a (b)(6) year old patient.The doctor had to improvise to complete the procedure.Incident occurred during treatment with instruments outside the patient.No delay was reported.No other complications were reported.

Manufacturer Narrative

The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.According to clinical/medical investigation, one undated photo was provided for review, it shows the device in situ, however the photo does not contribute to the root cause of the reported events.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history revealed prior complaints for the listed part.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.The potential probable causes for this event could include but not limited to a patient condition, user or procedural error.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: SPATIAL FRAME STRUT EXT SHT
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11465663
• MDR Text Key: 239349869
• Report Number: 1020279-2021-02003
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 03596010552204
• UDI-Public: 03596010552204
• Combination Product (y/n): N
• PMA/PMN Number: K994143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71070200
• Device Catalogue Number: 71070200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention