MAUDE Adverse Event Report: AEQUALIS GLENOID AND REVERSED PIN; SURGICAL ORTHOPEDIC INSTRUMENT

Model Number DIAM.2.5MM LENGTH 200MM

Device Problem Material Fragmentation (1261)

Patient Problems Awareness during Anaesthesia (1707); Device Embedded In Tissue or Plaque (3165)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

Event Description

"we had a (b)(4) guide pin break off in a patient glenoid this morning.The surgeon (mark schrumpf) was drilling and placing the guide wire, he drilled it into the glenoid and then pulled it back out to check his placement and realized the threaded tip had broken off and was lodged in the bone.We tried to go after it with a trephine from a broken screw set, but it fell behind the glenoid.We used x-ray to verify its position, determined that it was in a 'safe' place laying between muscle and bone, and it would be more harmful to try and remove it.It was left inside and the case was completed without further incident.".

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS GLENOID AND REVERSED PIN
• Type of Device: SURGICAL ORTHOPEDIC INSTRUMENT
• MDR Report Key: 9792186
• MDR Text Key: 190038121
• Report Number: 3000931034-2020-00029
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DIAM.2.5MM LENGTH 200MM
• Device Catalogue Number: DWD063
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other