MAUDE Adverse Event Report: DRILL,2.3MM,22MM; DENTAL DRILL

Catalog Number SV2.3DN

Device Problem Vibration (1674)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Patient identifier is unknown / not provided.Age at time of event is unknown / not provided.Patient weight is unknown / not provided.Lot number is unknown / not provided.Initial reporter email address is unknown / not provided.

Event Description

It was reported that drill wobbling when used the first time.

Event Description

No additional or corrected information to report.

Manufacturer Narrative

This report is being submitted to report corrected information.Upon further review, it was determined that the event is not a reportable malfunction.No further medwatch reports will be submitted for this event.The following sections are being reported: h2: if follow-up, what type h10: additional narratives/data.

• Brand Name: DRILL,2.3MM,22MM
• Type of Device: DENTAL DRILL
• MDR Report Key: 12602524
• MDR Text Key: 275869832
• Report Number: 0002023141-2021-02815
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SV2.3DN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1