MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30660095S

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

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

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that the patient underwent gamma3 u-lag screw surgery on (b)(6) 2019.After the surgery, the cutout of u-lag screw and the bending of u-blade were confirmed.Then gamma3 extraction and revision to tha was performed on (b)(6) 2019.

Manufacturer Narrative

The reported event that u-blade set, ti gamma3® ø10.5x95mm was allegedly cut out issue could be confirmed, based on evaluation of x-rays and returned device.Visual inspection revealed that the received u-blade set shows traces of use.Marks of bearing points were observed on lag screw surface.Both the blades were heavily bent outword from centre axis of the u-blade.Based on investigation, the root cause was attributed to a patient related issue.In case of a cut-out, the femur neck slips over the lag screw ¿ in most of the cases due to torsional displacement and / or poor bone substances.As patient is 89 years old female, poor bone quality could have led to cutout of u-lag screw.The rmf considers that a revision surgery due to cut out or medialization is a typical complication of proximal femoral nailing.This harm does not primly depend on the implant.It is mostly caused by the kind of fracture, patient's general condition (osteoporosis), and primly the respective surgical technique.In the case of a cut out an extensive damage of the hip joint would result which has to be treated with arthroplasty.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The ifu instructs user that, ¿conditions attributable to non-union, osteoporosis, osteomalicia, 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.¿ if any further information is provided, the complaint report will be updated.

Event Description

It was reported that the patient underwent gamma3 u-lag screw surgery on (b)(6) 2019.After the surgery, the cutout of u-lag screw and the bending of u-blade were confirmed.Then gamma3 extraction and revision to tha was performed on (b)(6) 2019.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X95MM
• 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: 8482949
• MDR Text Key: 140918506
• Report Number: 0009610622-2019-00134
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540595997
• UDI-Public: 04546540595997
• Combination Product (y/n): N
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 30660095S
• Device Lot Number: K0EB4B4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 48