MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA IMPLANT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/18/2019

Event Type  Injury  

Event Description

It was reported by the hospital scrub tech that during case a revision surgery tensioner was making a clicking sound inside as they were tensioning cable, did not affect case, but needs to be checked, also both accord drivers are stripping and not grabbing screws tightly.No delays reported.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, no relevant clinical medical information was provided to conduct a thorough medical assessment.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re opened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) and/or (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) no relevant clinical medical information was provided to conduct a thorough medical assessment.

• Brand Name: TRAUMA IMPLANT
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8345680
• MDR Text Key: 136345483
• Report Number: 1020279-2019-00584
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention