MAUDE Adverse Event Report: OSTEOMED OSTEOPOWER SERIES III STRAIGHT DRILL; 1:1 STRAIGHT ASSEMBLY

Catalog Number 450-0777

Device Problem Failure To Service (1563)

Patient Problem Burn(s) (1757)

Event Date 04/21/2014

Event Type  Injury  

Event Description

During surgery 450-0777 osteopower series iii straight drill got hot and burned a pt's lip.Pt is in good condition and receiving post-operative care.

Manufacturer Narrative

The product was returned for eval.Diagnosis revealed that the module is noisy and overheating due to broken and worn components.Past service history was analyzed for the 450-0777 unit (b)(4).Last time the straight drill was serviced by osteomed was in september of 2012.Lack of maintenance, cleaning and lubrication can result in heat buildup.The requirement for the osteopower straight drill is to periodically return it to osteomed for maintenance.The burr was not returned for eval.

• Brand Name: OSTEOPOWER SERIES III STRAIGHT DRILL
• Type of Device: 1:1 STRAIGHT ASSEMBLY
• Manufacturer (Section D): OSTEOMED; 3885 arapaho rd.; addison TX 75001
• Manufacturer Contact: sophy george ; 3885 arapaho rd.; addison, TX 75001 ; 9728213342
• MDR Report Key: 3835997
• MDR Text Key: 21448365
• Report Number: 2027754-2014-00007
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 450-0777
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 59