MAUDE Adverse Event Report: STRYKER TRAUMA KIEL COUNTERBORE DRILL, LONG IMN INSTRUMENTS 5.5MMX255MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	2351-5510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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: "the patient underwent the initial procedure for femur (right).When the surgeon used the subject product, counterbore drill according to the advanced locking screw insertion procedure, the drill broke".
Additional Manufacturer Narrative
The reported event was confirmed.Review of the dhr revealed the item had been manufactured to specs.Review of risk management file (rmf), capa and complaint history revealed no salience.The device received was completely broken in the recess in front of the transition to the wider diameter at the connection adapter.The fracture pattern revealed a brittle fracture.It could not be excluded that the item had been used with a power tool under misalignment causing the adapter fragment to snap off at the weakest diameter.A manufacturing deficiency of the device was not verified.With available information and referring to investigation results the cause of the event was regarded being user related.
Event or Problem Description
As reported: "the patient underwent the initial procedure for femur (right).When the surgeon used the subject product, counterbore drill according to the advanced locking screw insertion procedure, the drill broke".

• Brand Name: COUNTERBORE DRILL, LONG IMN INSTRUMENTS 5.5MMX255MM
• 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: 11496819
• Report Number: 0009610622-2021-00420
• Device Sequence Number: 3858292
• Product Code: HWE
• UDI-Device Identifier: 07613327379532
• UDI-Public: 07613327379532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 2351-5510
• Device Catalogue Number: 23515510
• Device Lot Number: KP431895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1