MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA IMPLANT; NAIL, FIXATION, BONE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that during a literature study it was revealed that the proximal screw dislodges and was managed by reinserting the screw-in.

Manufacturer Narrative

It was reported from a literature study that the patient had the proximal screw dislodged and was managed by reinserting the screw-in.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that one photo with three combined x-ray images labeled figure 5 in the article was provided for review however it is unknown which patient the x-ray photo was from.Per the review the dislodgement of the proximal screw was found in high fracture close to cervicotrochanteric area making it difficult to obtain good reduction.Based on the literature review dislodgement of the proximal screw was due to difficult anatomical reduction and poor screw position.Since no patient harm is being alleged and no further harm is anticipated, no further assessment is warranted at this time.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: TRAUMA IMPLANT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9531666
• MDR Text Key: 173082548
• Report Number: 1020279-2019-04647
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention