MAUDE Adverse Event Report: CORNER LOC/FOUNDATION FUSION SOLUTIONS, LLC CORNER LOC SLAP HAMMER TUBE; GUIDE, SURGICAL, INSTRUMENT

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Event Description

Surgical technologist found broken threads (2 fragments) on cornerloc instrument (slap hammer tube) prior to handing to physician during procedure.Physician notified.Instrument assessed.Instrument and fragments sent with sales representative.Physician ordered x-ray and determined that not objects were retained from the instrument after x-ray was performed.Fda safety report id # (b)(4).

• Brand Name: CORNER LOC SLAP HAMMER TUBE
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): CORNER LOC/FOUNDATION FUSION SOLUTIONS, LLC; tulsa OK 74137
• MDR Report Key: 11100460
• MDR Text Key: 224869564
• Report Number: MW5098597
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): Y
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• 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 Age: 68 YR
• Patient Weight: 95