MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-4265
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "both drills were broken when drilling for the lateral stop in the most proximal part.During the first drilling, the drill was carefully advanced because it sounded like it was interfering with the nail, but it broke off in the middle stage.After re-tightening the nail, the second drill was used, but again there was an interfering sound, so the drill was pulled out and in more carefully, but it broke off in the middle stage as well.The most proximal hole was not used because two other holes had already been fixed in the proximal part before that.The surgeon speculated that the nail may have been bent due to the use of an 8-mm diameter nail in a case with a narrow medullary cavity.Preconnection check was performed before insertion.".
Additional Manufacturer Narrative
Please note correction to section h6 (component code).The reported event could be confirmed.The device inspection revealed the following: the drill is broken from 48mm of the flute region.Based on the state of the device, the functionality cannot be given anymore.The received drill shows signs of intense usage.The cutting edges that are blunt and damaged.The breakage surface reveals a smooth surface.Shiny areas were observe in the fracture region through microscopic analysis.Such signs indicate a sudden brittle fracture caused by excessive bending forces applied to the device.Based on investigation, the root cause was attributed to an user related issue.The failure was probably caused by an excessive bending force applied by healthcare professional to the worn out device.The device was manufactured in 2011, meaning it was used for almost 11 years.As a reminder, the ifu clearly states: "¿ always treat the instrument carefully to avoid surface damage or alterations to the geometry.¿ the design of the instrument must not be modified in any way.¿ ensure that the drilling and cutting tools to be used are sharp; discard them if they are not.Never attempt to sharpen drilling and cutting tools!¿." 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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "both drills were broken when drilling for the lateral stop in the most proximal part.During the first drilling, the drill was carefully advanced because it sounded like it was interfering with the nail, but it broke off in the middle stage.After re-tightening the nail, the second drill was used, but again there was an interfering sound, so the drill was pulled out and in more carefully, but it broke off in the middle stage as well.The most proximal hole was not used because two other holes had already been fixed in the proximal part before that.The surgeon speculated that the nail may have been bent due to the use of an 8-mm diameter nail in a case with a narrow medullary cavity.Preconnection check was performed before insertion.".

• Brand Name: DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13923304
• Report Number: 0009610622-2022-00105
• Device Sequence Number: 15034644
• 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): 07/06/2022

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: KU82200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown