MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø12X320 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18451232S
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The patient underwent t2recon surgery against subtrochanteric fracture on (b)(6) 2018.On (b)(6) 2018, the implanted nail broke under lag screw due to bone nonunion.The broken nail removal surgery was performed on (b)(6) 2018, and fixation by plate was performed against the bone nonunion.
Additional Manufacturer Narrative
The reported event that reconstruction nail r1.5, ti, right t2 recon was alleged of issue (implant breakage - nail) could be confirmed, since the device was returned for evaluation and it matches the reported failure mode.Visual inspection of the returned device confirmed that the nail was broken at the lag screw hole (proximal hole).Based on the visual inspection of fractured surface it can be concluded that the product has undergone typical brittle fracture due to high axial overload due to non-union.Areas with signs of friction / seizing (bearing points of the lag screw) are visible at the edges of the proximal hole.The material deformation was generated by friction between lag screw and nail resp.High axial load application due to non-union.Drill marks were found at the inside of proximal hole.This damage, intra-operatively caused by a deviated step drill, had most likely created the starting point of the nail breakage by a notching effect.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by overloading associated with delayed unions.Furthermore, due to the traces found at the edge of the proximal hole, it could not be excluded that the nail breakage was contributed by intra-operative damage caused by a deviated step drill.The affected implant is 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.This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.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 material, manufacturing or design related problems were found during the investigation.The instruction for use conveys that most frequent adverse effects involving the use of internal fracture fixation devices are: these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.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 or Problem Description
The patient underwent t2recon surgery against subtrochanteric fracture on (b)(6) 2018.On (b)(6) 2018, the implanted nail broke under lag screw due to bone nonunion.The broken nail removal surgery was perforemed on (b)(6) 2018, and fixation by plate was performed against the bone nonunion.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø12X320 MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7756133
• Report Number: 0009610622-2018-00526
• Device Sequence Number: 16473827
• Product Code: HSB
• UDI-Device Identifier: 04546540412782
• UDI-Public: 04546540412782
• Combination Product (Y/N): N
• PMA/510(K) Number: K102992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 18451232S
• Device Lot Number: K0880F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention