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

Model Number	AS14-R
Medical Device Problem Codes	Vibration (1674); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	Fatigue (1849)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report not confirmed.Evaluation could not reproduce the reported malfunction of flailing/wobble.However, it was noted that the bearings were worn with slight corrosion.This finding may have contributed to the user¿s experience.It was also noted that the color band and laser markings were faded and illegible.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.This report is not a complaint as there is no allegation of deficiency or serious injury.This is a repair request that was escalated for evaluation of reportability.It was determined this is not a reportable event and will be handled as a routine repair request.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Repair request initiated for device with the report of jumping drill and flailing.No patient impact reported.Repair request escalated to a product event based on reason for return.On follow up, it was confirmed that there was no patient impact, however due to jumping and skipping of the drill, it caused fatigue to the arms/hands of the health care professional.Additional information is currently being requested regarding the event and the current status of the health care professional.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow-up, it was reported that no additional information can be provided for the current status of the health care professional.

• Brand Name: LEGEND STRAIGHT 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: 8912200
• Report Number: 1625507-2019-00089
• Device Sequence Number: 19182545
• Product Code: HBB
• UDI-Device Identifier: 00613994421890
• UDI-Public: 00613994421890
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/03/2019

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 Model Number: AS14-R
• Device Catalogue Number: AS14-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/03/2019
• 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