MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 FEMUR 4,2X340 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-4265
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported, "t2 ankle nail surgery.When drilling to the most distal part of the nail, the drill advanced outside the nail (intrabone).At that time, the tip of the drill (1806-4265) broke about 3 cm.The broken drill was removed with forceps.".
Event or Problem Description
As reported: "t2 ankle nail surgery.When drilling to the most distal part of the nail, the drill advanced outside the nail (intrabone).At that time, the tip of the drill (1806-4265) broke about 3 cm.The broken drill was removed with forceps.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received drills showed traces of a frequent and intense use.The cutting thread of the drills are also worn out.It was broken approx.30 mm from the tip.The broken off piece was also returned.The breakage surface shows a typical smooth surface of a forced brittle fracture.Plastic deformation along the breakage surface was not found.The received device conforms to the hardness and dimensional specifications as given in the drawing.Diameter of the received drill is 4.155 mm (range: 4.1-4.2 mm).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿avoid drilling into metal implants with bone drills.The implants could be critically weakened and break under load and the drill could be damaged.¿.Based on investigation, the root cause was attributed to a user related issue.Appearance of the breakage surface as well as the absence of plastic deformation suggested that the drill broke in a sudden manner.The breakage of the tip seems to be a forceful fracture while drilling it forcefully in a relatively harder bone.If any further information is provided, the complaint report will be updated.

• Brand Name: DRILL, TRI-FLAT T2 FEMUR 4,2X340 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11016069
• Report Number: 0009610622-2020-00990
• Device Sequence Number: 3944390
• Product Code: HWE
• UDI-Device Identifier: 04546540196781
• UDI-Public: 04546540196781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 1806-4265
• Device Catalogue Number: 18064265
• Device Lot Number: KU63315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 53