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 Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/19/2020
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: "while drilling in order to insert oblique screw, a drill interfered with nail.Drill got broken and the tip remained in bone.The tip was removed.Screw was inserted to another site and procedure was completed.".
Additional Manufacturer Narrative
Corrections in d10/h3 the reported event that drill, tri-flat t2 femur ø4,2x340 mm was alleged of issue ¿instrument - breakage during implantation¿ could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.Due to the current covid-19 sanitary crisis, it was not possible to receive the product to the product assessment center for the time being.The investigation will be reassessed as soon as the product is received.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, looking at the event and the kind of failure and the damage, the most probable cause could be a misaligned forceful drilling, to an extent that the drill came in contact with the nail, it broke and deformed the inner sleeve as well (due to misalignment).A blunt drill bit due to long years of usage cannot be excluded as one of the contributors.A prior inspection of the drill and functional check of the targeting device may have avoided the failure.This is required as per ifu.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device return restricted due to pandemic.
Event or Problem Description
As reported: "while drilling in order to insert oblique screw, a drill interfered with nail.Drill got broken and the tip remained in bone.The tip was removed.Screw was inserted to another site and procedure was completed.".
Event or Problem Description
As reported: "while drilling in order to insert oblique screw, a drill interfered with nail.Drill got broken and the tip remained in bone.The tip was removed.Screw was inserted to another site and procedure was completed.".
Additional Manufacturer Narrative
Correction: refer to h3 (reason code).The reported event that drill, tri-flat t2 femur ø4,2x340 mm was alleged of issue ¿instrument - breakage during implantation¿ could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, looking at the event and the kind of failure and the damage, the most probable cause could be a misaligned forceful drilling, to an extent that the drill came in contact with the nail, it broke and deformed the inner sleeve as well (due to misalignment).A blunt drill bit due to long years of usage cannot be excluded as one of the contributors.A prior inspection of the drill and functional check of the targeting device may have avoided the failure.This is required as per ifu.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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; DE D-24232
• MDR Report Key: 9966002
• Report Number: 0009610622-2020-00153
• Device Sequence Number: 3881509
• Product Code: HWE
• UDI-Device Identifier: 04546540196781
• UDI-Public: 04546540196781
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/19/2020

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: 1806-4265
• Device Catalogue Number: 18064265
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020; 07/23/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/15/2020; 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1