MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31250170S

Device Problem Break (1069)

Patient Problems Fall (1848); Non-union Bone Fracture (2369)

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2015, the patient underwent the surgery with the g3 nail.Afterwards, the fracture part was non-union.(b)(6) 2015, the patient fell down.The surgeon confirmed x-ray on (b)(6) 2016.And he found that the nail was broken.Therefore, the surgeon is planning revision surgery for the patient.

Manufacturer Narrative

The review of manufacturing documents revealed no deviation in the manufacturing process resp.No deviation in material.Potential nail breakage had been considered in the corresponding rmf.The threshold was not exceeded.A review of the capa database revealed no corrective actions related to the reported event in place for the subject product.The event did not involve a product problem indicating a non-conformity, adverse trend or unanticipated hazard.No further action is required at this time.As no item was returned no physical examination could be carried out.General aspects: the gamma3 nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation.During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product.Usually a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Generally the risk of a breakage will increase with the increase of load cycles and load level.Nail breakage in general has been experienced, but does not present an unanticipated event in itself.Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Additional trauma / fall - a nail breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.In this case, referring to received information, the nail allegedly broke after an implantation period of approx.6 months.The reported event ¿ nail breakage ¿ could not be confirmed, since the device was not returned for evaluation nor were any x-rays provided showing a nail breakage.Implant breakage may occur when the material is subjected to repeated loading and unloading resulting in fatigue of material.If the loads are above a certain threshold (microscopic) cracks will begin to form on the surface.A requirement for successful treatment with an intramedullary nail is that bone healing develops in a sufficient manner that the implant is relieved by load sharing / load transmission over the bone.Otherwise the implant may be subject to a fatigue fracture.In this case insufficient bone healing (non-union) and additional significant load (fall) had been applied to the nail.It could not be excluded that this exceeding load application had contributed to the event.Further, it remained open if the patient had been compliant during the implantation period.As the nail was not available it could not be determined if the nail had been damaged intra-operatively.With available information no further technical statement was possible.As to missing medical records no medical statement was possible.The file will be closed formally.In case relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.With available information a deficiency of the nail could not be verified.Device was not received.

Event Description

On (b)(6) 2015, the patient underwent the surgery with the g3 nail.Afterwards, the fracture part was non-union.(b)(6) 2015, the patient fell down.The surgeon confirmed x-ray on (b)(6) 2016.And he found that the nail was broken.Therefore, the surgeon is planning revision surgery for the patient.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°
• 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: 5398858
• MDR Text Key: 37130046
• Report Number: 0009610622-2016-00037
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 31250170S
• Device Lot Number: K0C9AA2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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