MAUDE Adverse Event Report: STERILMED, INC. DRILL BIT QUICK COUPLING (GOLD); BIT, DRILL

Model Number	SYN310.23
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue could not be confirmed because the product said to be involved was discarded.Therefore, the visual and functional inspections could not be performed.In addition, a manufacturing record evaluation could not be performed since no lot number was not provided.Manufacture report numbers 2134070-2020-00017 and 2134070-2020-00018 are related to the same event.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an open reduction and internal fixation distal tibia procedure with three drill bit quick coupling (gold), and all three drill bits were dull.A stryker battery powered handpiece was used.This caused extended time in the operating room.However, there was no patient consequence.

• Brand Name: DRILL BIT QUICK COUPLING (GOLD)
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 11057659
• Report Number: 2134070-2020-00016
• Device Sequence Number: 4396801
• Product Code: HTW
• UDI-Device Identifier: 10888551029957
• UDI-Public: 10888551029957
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SYN310.23
• Device Catalogue Number: SYN310.23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1