MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM CVD PROX HUM PL 9H R 147MM; PIN, FIXATION, THREADED, METALLIC

Catalog Number UNKNOWN

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 for treatment, was not returned for evaluation.Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed.According to clinical/medical investigation, 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.The potential probable causes for this event could include but not limited to a user or procedural error.No further 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.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: EVOS 3.5MM CVD PROX HUM PL 9H R 147MM
• Type of Device: PIN, FIXATION, THREADED, METALLIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10946046
• MDR Text Key: 219513995
• Report Number: 1020279-2020-06970
• 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: 06/01/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PLATE 72467209, LOT UNKNOWN; PLATE 72467209, LOT UNKNOWN
• Patient Outcome(s): Other