MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN EVOS PLATING SCREW; PIN, FIXATION, THREADED, METALLIC

Catalog Number UNKN02200302

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Subluxation (4525)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that patient x-ray showed 3.5mm locking screws in the shaft of the plate (x3) were found to have loosened and backed out completely from the plate holes.No information about medical interventions was initially provided.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation but the pictures were reviewed and the failure mode was confirmed.The clinical / medical investigation concluded that, the single undated, unlabeled x-ray provided showed a non-union and a 3.5mm locking screws in the shaft of the plate (x3) were noted to have loosened and backed out completely from the plate holes.However, without the previous images, dates, timing or activity level of the patient the root cause of the screws backing cannot be determined.Based on the limited information provided the impact to the patient beyond the non-union cannot be determined.Currently it is unknown known if the surgeon has scheduled any additional procedures for this patient.Therefore, no further clinical/medical assessment 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.Some potential probable causes for this event could include a fit/sizing issue, traumatic injury or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.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: UNKN EVOS PLATING SCREW
• Type of Device: PIN, FIXATION, THREADED, METALLIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10946146
• MDR Text Key: 219517496
• Report Number: 1020279-2020-06972
• Device Sequence Number: 1
• Product Code: NDM
• 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: 06/28/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02200302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 72467209
• Patient Outcome(s): Other; Required Intervention