MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø11X200MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18181120S

Device Problem Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Aan failed and broke inside of the patient.The patient felt pain and the x-ray showed that the nail was off.The arthroplasty was healed, so they took out the nail and no further treatment was needed.

Event Description

Aan failed and broke inside of the patient.The patient felt pain and the x-ray showed that the nail was off.The arthroplasty was healed so they took out the nail and no further treatment was needed.

Manufacturer Narrative

Evaluation revealed the broken nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.Dimensional accuracy was confirmed on returned nail.Available information revealed that the nail allegedly broke after an unknown period of implantation but had been released for full mobilization.General aspects: an implant will be subject of a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.Temporary implants are designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.Physical evaluation revealed that the nail broke in a fatigue fracture most likely after bony consolidation ¿ here: arthrodesis.Potential causes for events resp.Warnings are listed in the labelling.In this case the nail broke in an area with the smallest cross section and the highest bending stresses appear because locked to the talar and more proximal to the tibia.As the bone fragments had healed together 2 different material elasticities contribute against each other.On one hand the rigid nail and on the other hand a more elastic bone section.In such situation the bone motion is still loading the nail consequently leading to permanent stresses and resulting in fatigue fracture of the nail.Based on the above the nail breakage was not linked to a deficiency of the device but was mainly caused by patient factors.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There were no actions in place related to the reported event for the subject product.No non-conformity was identified.The event was not linked to a deficiency of the device.In case further substantive information will be received we reserve the right to update the investigation and change the root cause.

• Brand Name: ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø11X200MM
• 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: 7132543
• MDR Text Key: 95318508
• Report Number: 0009610622-2017-00381
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K051590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 18181120S
• Device Lot Number: K081C35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention