MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS LEGEND ATTACHMENT TT12C; MOTOR, DRILL, PNEUMATIC

Model Number	TT12C
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the tt12c tube was received with a t12mh25 tool lodged inside.It was identified that the bearing came apart is the distal bearing of the tube and all internal tube components for distal end of the tube were present except for the bearing balls.It was also noted that there was heat discoloration present on most of the shaft of the tool.The likely cause of failure is consistent with tool that was used in an inadequately cleaned telescoping tube.Bio-residue bakes to inner race and shaft at bearing distal to tube end.Once motion is restricted between shaft and inner race, excessive heat and loads are created both damaging bearing and tool.The device user manual warnings section includes instructions to properly clean all reusable devices prior to use.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 the tip of the device came apart and ball bearings fell into the wound.No patient impact reported.There was 20 mins.Delay.On follow- up it was confirmed that 4 out of 6 ball bearings were removed from the patient and the procedure was completed with no further issue.It was also noted that the current status of the patient post-surgery is doing well.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: LEGEND ATTACHMENT TT12C
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 7684405
• Report Number: 1625507-2018-00033
• Device Sequence Number: 10933719
• Product Code: HBB
• UDI-Device Identifier: 00613994418739
• UDI-Public: 00613994418739
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: TT12C
• Device Catalogue Number: TT12C
• Device Lot Number: P06824619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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: 60 YR
• Patient Weight: 184