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

Catalog Number 30660095S

Device Problem Cut In Material (2454)

Patient Problem No Information (3190)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Implanted the gamma lomg nail on (b)(6) 2016.It was confirmed a cut out for the screw of the gamma on middle of dec.Removed the gamma and implanted another artificial head bone and locking plate by surgical procedure.

Manufacturer Narrative

The evaluation revealed the u-blade lag screw set to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).During review no material, design or manufacturing related issues were found.The basics of the gamma3-system are the interaction of nail kit including a set screw and lag screw / u-blade set in the proximal area.The intention is to allow the fracture site to subside (if the fracture gap is too big) in order to support bone union.This requires motion in a relative rigid construction and is solved by lateralization of the lag screw.The set screw ¿ as part of the nail kit - is designed to fit into one of the four grooves of the shaft of the lag screw with ascending shapes at both medial and lateral.This prevents both rotation and complete migration of the lag screw but allows sliding in a limited and defined range.In addition to above the use of a u-blade set supports rotation control of a femur neck with potentially poor bone substance.In this case the evidences on lag screw and set screw suggested that both components initially had been placed as intended.Different positions of bearing points suggested that the lag screw had lateralized ¿ potentially as intended.The mark in the sliding flute of the lag screw at medial ¿ at the ascending area ¿ suggests that the set screw had reached the final position in the lag screw flute.Referring to found evidences on the implants it was concluded that the patient actually suffered from a cutout.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.A functional test with returned nail and its set screw and with the returned lag screw (without damaged u-blade) revealed that function was given in full.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.The basics of the gamma-system (shown in below sketch) are the interaction of nail set including a set screw and lag screw in the proximal area.Review of complaint history, 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 non-conformity was identified.It could not be determined why resp.Under which circumstances the u-blade had become bent.It was not suspected that this damage had contributed to the event.The file will be closed formally.In case relevant information resp.The part(s) become available we reserve the right to update the investigation and to change the root cause.With available information a deficiency of the u-blade set was not verified.

Event Description

Implanted the gamma lomg nail on (b)(6) 2016.It was confirmed a cut out for the screw of the gamma on middle of (b)(6).Removed the gamma and implanted another artificial head bone and locking plate by surgical procedure.

• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6309221
• MDR Text Key: 66760324
• Report Number: 0009610622-2017-00048
• Device Sequence Number: 1
• Product Code: HSB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 30660095S
• Device Lot Number: K03584A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention