MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 35200280S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pneumonia (2011)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

On(b)(6) 2016, gamma3 primary surgery was performed.One week after surgery, the rotation of the femoral head was found slightly.Two weeks after surgery, the cutout of the u-lag screw was found.Because of pneumonia, the revision surgery is not planned at present.The patient is low activity and using a wheelchair.

Manufacturer Narrative

The evaluation revealed the u-blade set, ti gamma3® ø10.5x95mm and the long nail kit r1.5, ti, left gamma3® ø10x280mm x 120° to be both subject products.The end cap as well as both locking screws are classified as concomitant products and thus, not subject of this report.No deviations were found during review of the manufacturing and inspection documents (dhr).The items were documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.As the devices are still implanted and thus, not available for evaluation, investigation is limited on x-rays of medium quality provided.Revision surgery due to cut out 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 (correct positioning of the lag screw in the center of the femoral head).In the case of a cut out an extensive damage of the hip joint would result which has to be treated with arthroplasty.In many cases a permanent harm would result from such an event (s4).According to literature the rate of cut out is 1 - 5 % (o5) with any implant which is currently available on the market.Though it is estimated as "high risk" the devices in question are best state of the art and there are no possibilities for further mitigation of the risk from a clinical point of view (see "sketch of intended interaction of lag screw / set screw from op-tech").From a technical point of view, it was concluded that the femoral neck had rotated over the lag screw, whilst the femoral head was penetrated by the tip of the lag screw, which presents a cut-out after an implantation period of only two weeks.In the case presented, the lag screw was not placed in the center of the femoral head but very inferior, which is suboptimal (see photo [2]).Like already stated in the event description after only one week post-operatively on the x-ray it is clearly visible that the femoral head had rotated slightly over the lag screw (see photo [3]).The x-ray taken two weeks post-operatively clearly shows the cut out (see photo [4]).The intended lateralization of the lag screw did only marginally occur as seen on the x-rays.Most likely the set screw was tight at the lag screw for some reason preventing further lateralization.Due to the too static construct of the implants the femoral head rotated and slipped over the lag screw resulting in cut out.As the nail, set screw and lag screw are not available for evaluation the exact fit of the implants cannot be reproduced on the basis of e.G.Imprints and abrasion.Any substantive patient data were not available either.Thus, a more precise statement regarding the root cause for the cut out is not possible.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.

Event Description

On (b)(6) 2016, gamma3 primary surgery was performed.One week after surgery, the rotation of the femoral head was found slightly.Two weeks after surgery, the cutout of the u-lag screw was found.Because of pneumonia, the revision surgery is not planned at present.The patient is low activity and using a wheelchair.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 120°
• 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: 5498965
• MDR Text Key: 40303876
• Report Number: 0009610622-2016-00126
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K043002
• 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: 02/18/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 35200280S
• Device Lot Number: K068EEE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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