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

Model Number 1895-5001S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.

Event 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.".

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.

Event 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.".

• Brand Name: CONDYLE SCREW NUT T2 FEMUR 5 MM
• Type of Device: 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: 11113676
• MDR Text Key: 225998780
• Report Number: 0009610622-2021-00009
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202109
• UDI-Public: 04546540202109
• Combination Product (y/n): N
• PMA/PMN Number: K014220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1895-5001S
• Device Catalogue Number: 18955001S
• Device Lot Number: K06CD0A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention