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

Catalog Number 18955001S

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 112704783
• Report Number: 0009610622-2018-00250
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202109
• UDI-Public: 04546540202109
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR