MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS TOOL MR8 DISSECTING; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	MR8-10MH17
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device was discarded.The user manual contains the following warning ¿do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff.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 cervical fusion tip of the blade broke off and the piece remained inside the patient.On follow up, no information available on patient condition post surgery and procedure delay.It was reported that there is no back up device used.Additional information is still on follow-up.
Additional Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device was discarded.The user manual contains the following warning ¿do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff.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 cervical fusion tip of the blade broke off and the piece remained inside the patient.On follow up, no information available on patient condition post surgery and procedure delay.It was reported that there is no back up device used.Additional information is still on follow-up.

• Brand Name: TOOL MR8 DISSECTING
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: glen belmer ; 7000 central avenue ne; ft. worth, TX 76137-3291 ; 6122713209
• MDR Report Key: 13125373
• Report Number: 1625507-2021-00395
• Device Sequence Number: 17269517
• Product Code: HBE
• UDI-Device Identifier: 00643169989603
• UDI-Public: 00643169989603
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2021

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 Expiration Date: 08/08/2026
• Device Model Number: MR8-10MH17
• Device Catalogue Number: MR8-10MH17
• Device Lot Number: 0222557152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 99 KG