MAUDE Adverse Event Report: STERILMED, INC. DRILL BIT TWIST QUICK CONNECT; BIT, DRILL

Model Number	KOMKM166-310-19
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact event date is unknown, however event occurred in (b)(6) 2020.The device has not been returned for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an orthopedic procedure with a reprocessed drill bit twist quick connect and the 2.0 mm drill bit broke at approximately 1.7 mm during surgery.The broken piece was retrieved.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: DRILL BIT TWIST QUICK CONNECT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 11382154
• Report Number: 2134070-2021-00002
• Device Sequence Number: 11728778
• Product Code: HTW
• UDI-Device Identifier: 10888551016483
• UDI-Public: 10888551016483
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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: KOMKM166-310-19
• Device Catalogue Number: KOMKM166-310-19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 78