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 Code	Failure of Implant (1924)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "a patient underwent an orif for distal femur on (b)(6) 2020.On unknown date, two screws of condyle came off and the patient had revision surgery on (b)(6) 2020.".
Event or Problem Description
As reported: "a patient underwent an orif for distal femur on (b)(6) 2020.On unknown date, two screws of condyle came off and the patient had revision surgery on (b)(6) 2020.".
Additional Manufacturer Narrative
The reported event was not confirmed.No evidence such as x-rays or medical records were available to prove the event.Review of device history, labelling, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of material, manufacturing or design related problems were found during the document review.A condyle screw nut has a counterpart called condyle screw.In this case the corresponding condyle screws were not reported nor were any information given because of the reporting hp¿s policy.Based on available information it could not be determined which reasons had caused the event.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.

• 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: 11113751
• Report Number: 0009610622-2021-00010
• Device Sequence Number: 17068462
• Product Code: HSB
• UDI-Device Identifier: 04546540202109
• UDI-Public: 04546540202109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K014220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2025
• Device Model Number: 1895-5001S
• Device Catalogue Number: 18955001S
• Device Lot Number: K06CD0A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention