MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS TBD; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	T12MH25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inconclusive.The device has been returned and is still pending their evaluation results.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.(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a tool broke off in a patient.An x-ray procedure was conducted to locate the broken piece but it cannot be found.On follow up, it was confirmed with hcp that there was no staff and patient impact.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tool returned was used and broken.The tang piece of the tool was returned however the head piece of the tool was not returned.It was noted there was discoloration at and near the fracture location and the fracture location is relative to location of the distal bearings in tt12 and variant telescoping tubes.The likely cause was identified as the distal bearings are no longer supporting the tool effectively and the telescoping tube used with this t12mh25 tool has been used past its functional life.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 a tool broke off in a patient.An x-ray procedure was conducted to locate the broken piece but it cannot be found.On follow up, it was confirmed with hcp that there was no staff and patient impact.

• Brand Name: TBD
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 8304219
• Report Number: 1625507-2019-00006
• Device Sequence Number: 18846934
• Product Code: HBE
• UDI-Device Identifier: 00643169766365
• UDI-Public: 00643169766365
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 10/24/2023
• Device Model Number: T12MH25
• Device Catalogue Number: T12MH25
• Device Lot Number: H5481699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/26/2019
• 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