MAUDE Adverse Event Report: INSTRUMENT, SCREWDRIVER, MANUAL, SURGICAL USE; INSTRUMENT, MANUAL, SURGICAL USE

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/04/2020

Event Type  malfunction  

Event Description

Pt in surgery for podiatry surgery.Surgeon using an arthrex forefoot internal brace implant system with two 3 x 8 mm peek tenodesis screws with disposable drivers.The inserter snapped off within the tenodesis screw that was inserted to secure the fiber tape in the metatarsal head.Efforts were made to remove the inserter from the area; however, they were unsuccessful.It was deemed that more damage would be done to the pt by trying to take this out versus leaving it in, so the inserter was left within the tenodesis screw.Fda safety report id# (b)(4).

• Brand Name: INSTRUMENT, SCREWDRIVER, MANUAL, SURGICAL USE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL USE
• MDR Report Key: 9686768
• MDR Text Key: 178580081
• Report Number: MW5092864
• Device Sequence Number: 2
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2020
• 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 Age: 18 YR
• Patient Weight: 50