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 too big and bulky for a (b)(6) 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 device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, 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 complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.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: 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: 11465545
• MDR Text Key: 239223399
• Report Number: 1020279-2021-01999
• 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: 09/14/2021

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: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention