MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONDYLE SCREW NUT T2 FEMUR Ø5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18955001S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that after the first revision surgery((b)(6) 2018), breakage of the screw which was replaced in the revision surgery and most proximal condylar screw were found on (b)(6) 2018.Revision reported under pi (b)(4).Second revision surgery was performed on (b)(6) 2018 and breakage of the all of implanted screws were found during the revision surgery.In the second revision surgery, all of the implants including the nail were replaced.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
It was reported that after the first revision surgery(3/9/2018), breakage of the screw which was replaced in the revision surgery and most proximal condylar screw were found on 3/19/2018.Revision reported under pi 1700980.Second revision surgery was performed on 3/30/2018 and breakage of the all of implanted screws were found during the revision surgery.In the second revision surgery, all of the implants including the nail were replaced.

• Brand Name: CONDYLE SCREW NUT T2 FEMUR Ø5 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
• MDR Report Key: 7648629
• Report Number: 0009610622-2018-00250
• Device Sequence Number: 2481853
• Product Code: HSB
• UDI-Device Identifier: 04546540202109
• UDI-Public: 04546540202109
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• 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
• Report Date (Section B): 07/27/2018

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: 10/31/2022
• Device Catalogue Number: 18955001S
• Device Lot Number: K092AE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/27/2018
• 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
• Patient Age: 74 YR