MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH FRIOS MICROSAW DRILLS; HANDPIECE, ROTARY BONE CUTTING

Catalog Number 32905046

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

In this event it was reported that a dentist used a frios microsaw and accompanying frios microsaw drills.The dentist reported that one of the drills broke and the remnant was too close to the periapical area of an adjacent tooth to safely remove it without potentially harming the tooth.

Manufacturer Narrative

No product is available for analysis to determine the mode of failure.Since the remnant remains in situ and may require additional surgical intervention to remove it in the future, this event meets the criteria for a reportable event per 21 cfr part 803.The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: FRIOS MICROSAW DRILLS
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; mannheim ; GM
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4380054
• MDR Text Key: 5289315
• Report Number: 9681851-2014-00018
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K994298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32905046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention