MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS LEGEND ANGLED ATTACHMENT; MOTOR, DRILL, PNEUMATIC

Model Number	AA07
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inconclusive.Evaluation could not be performed because the device has been returned but still has pending evaluation results.The device user manual warnings section includes instructions that heavy side loads and/or long operating times may cause the device to overheat.If the device overheats, discontinue use and rest the device by using it intermittently, or wrap the device in a moist sterile towel.Use of an overheated device may cause injury to the patient or operator.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during an operation, the hand piece began to heat quite quickly and intensely.At the end of the procedure, the team found that the patient has a small burn type lesion at the edge of the surgical opening.The hand piece was used the next day and presented no problem.The patient was alive with injury.
Additional Manufacturer Narrative
No conclusion can be drawn.Evaluation could not be performed because the tool cannot be inserted during pre-repair tests, making it not operational to conduct heat test.It was noted that the distal and tube bearings were broken and detached, both flanged and non flanged bearings were corroded, and the color ring and laser markings were faded.This finding may have contributed to the user's experience.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient is alive with injury and that no additional treatment was needed post - surgery.The patient is now healing.

• Brand Name: LEGEND ANGLED ATTACHMENT
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 8004310
• Report Number: 1625507-2018-00065
• Device Sequence Number: 16441605
• Product Code: HBB
• UDI-Device Identifier: 00643169740983
• UDI-Public: 00643169740983
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AA07
• Device Catalogue Number: AA07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Weight: 81