MAUDE Adverse Event Report: SYNTHES USA 90' SCREWDRIVER

Model Number 03.505.003

Device Problems Entrapment of Device (1212); Material Separation (1562); Output Problem (3005)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/18/2021

Event Type  Injury  

Event Description

Trauma patient in or.Patient had 2 procedures, rib plating and orif for ulnar fracture from mva.Device used to secure screws came apart vs.Failed at end of procedure for rib plating.Device rep called to notify and advise.Primary surgeon well familiar with device (been using it for 8+ years and actually trialed device when in (b)(6)).Operating room felt all pieces were accounted for.Nothing found in thoracic cavity.Second surgeon came in to complete orif of ulna.Chest x-ray ordered after closure at end of both procedures to confirm chest tube placement and lung status.X-ray significant for foreign object in subcutaneous tissue.Surgeon notified.Patient reopened for removal of rfo.Patient was not removed from the operating room and was not extubated from initial procedure.Fda safety report id# (b)(4).

• Brand Name: 90' SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES USA; west chester PA 19380
• MDR Report Key: 11588340
• MDR Text Key: 243136898
• Report Number: MW5100352
• Device Sequence Number: 1
• Product Code: HXX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.003
• Device Catalogue Number: 03505003
• Device Lot Number: 814551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 116