MAUDE Adverse Event Report: AO SMALL DRILL; ARTHROSCOPE

Model Number 4100110000

Device Problem Material Disintegration (1177)

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

Event Date 08/03/2021

Event Type  malfunction  

Event Description

The user facility reported that the device had metal shavings coming out during a procedure. there was no patient impact, no delay, no medical intervention, and no adverse consequences.

Event Description

The user facility reported that the device had metal shavings coming out during a procedure.  there was no patient impact, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

Correction: d9, h3.Additional info h6 h3 other text : device not returned.

• Brand Name: AO SMALL DRILL
• Type of Device: ARTHROSCOPE
• MDR Report Key: 12380285
• MDR Text Key: 268565897
• Report Number: 3015967359-2021-01911
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540068156
• UDI-Public: 04546540068156
• Combination Product (y/n): N
• PMA/PMN Number: K112593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4100110000
• Device Catalogue Number: 4100110000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1