MAUDE Adverse Event Report: BRASSELER USA KM166-00-01 5/64 X 5" TWIST DRL TWIST DRILL

Catalog Number	5004048M2
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: the customer reported breakage during use and returned the used drill for evaluation.Visual observations of returned product shows bent shank and head bent and broken along cutting edge.Dimensional measurable attributes on the returned piece were in specification of the drawing.Review of receipt of materials was also to specification.Cutting evaluation was performed on the same part and showed no damage nor bending of product under intended use.Potential causes are excessive use of lateral force during procedure, use of excess force, inappropriate usage or combination with product coming into contact with metallic object.Per ifu-0039 = "do not use excessive, lateral, twisting or bending forces to prevent consumable accessory failure such as bending or breakage.Exercise extra caution when used with alignment guides or cutting fixtures.".
Event or Problem Description
The doctor was drilling into the patella.The drill bit broke in the patella.The broken piece was left in the patella.No follow-up was needed.

• Brand Name: KM166-00-01 5/64 X 5" TWIST DRL TWIST DRILL
• Common Device Name: TWIST DRILL
• Manufacturer (Section D): BRASSELER USA; 1 brasseler blvd; savannah GA 31419
• Manufacturer Contact: rod rylands ; 1 brasseler blvd; savannah, GA 31419 ; 4253087468
• MDR Report Key: 13862743
• Report Number: 2025102-2022-00004
• Device Sequence Number: 12098847
• Product Code: HTW
• UDI-Device Identifier: 00887919447917
• UDI-Public: (01)00887919447917(10)NV6Z2
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/22/2022

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 Catalogue Number: 5004048M2
• Device Lot Number: NV6Z2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male