MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONDYLE SCREW NUT T2 FEMUR 5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1895-5001S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
As reported: supracondylar fracture of the femur (right).T2scn.The nut on the condyle screw came out one week after the operation.There was no problem with the instrument.
Event or Problem Description
As reported: supracondylar fracture of the femur (right).T2scn.The nut on the condyle screw came out one week after the operation.There was no problem with the instrument.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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: ¿conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ 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, based on the labeling review, possible causes of failure could be user related (incorrect size selection, incorrect anatomical location, insufficient tightening of mating parts) and/or patient related (as patient is 80 years old, there are high chances of patient having osteoporotic bones, which may result into loosening of the device or premature loss of rigid fixation with the bone) if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: CONDYLE SCREW NUT T2 FEMUR 5 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10209224
• Report Number: 0009610622-2020-00306
• Device Sequence Number: 2405171
• Product Code: HSB
• UDI-Device Identifier: 04546540202109
• UDI-Public: 04546540202109
• Combination Product (Y/N): N
• PMA/510(K) Number: K014220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: Lay User/Patient
• Device Expiration Date: 02/28/2025
• Device Model Number: 1895-5001S
• Device Catalogue Number: 18955001S
• Device Lot Number: K03EAA6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 60